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Z-1902-2021Class II

Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number...

Ventec Life Systems, Inc. / initiated 2021-05-10 / Open, Classified / root cause: design
FDA source (opens on fda.gov)

Ventec Life Systems, Inc. began a recall of Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100... on . FDA classified it as Class II and gives the reason as "Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. The shutdown potentially prevents the ventilator from providing ventilation therapy". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number
Z-1902-2021
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Ventec Life Systems, Inc.
Product
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;
Product code
CBK Ventilator, Continuous, Facility Use
Reason for recall
Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. The shutdown potentially prevents the ventilator from providing ventilation therapy.
Root cause tag
design
FDA root cause
Device Design
Action
During the week of May 10, 2021, the firm sent an URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter via FedEx or overnight mail to customers informing them that due to malfunctions of the Control Board there is the potential of unexpected shut downs and/or lost of ventilator blower function. As a result, the ventilators may fail to provide ventilation therapy to the patients. Customers are instructed to complete the following clinical action until a replacement unit can be provided: Follow your procedures to transfer the patient to an alternative source of ventilation, if available. If no other ventilation method is available, you may continue to use the affected product adhering to the guidelines below: 1. Use only when the patient is actively monitored to ensure timely response to a potential malfunction. 2. Operate the ventilator as defined in the Instructions for Use and promptly respond to all alarms activated by the ventilator. 3. Use an external SpO2 monitor and set the alarm thresholds appropriately if the patient is oxygen dependent. 4. Connect the ventilator to an external monitoring system, wherever possible. In addition, Customers are to acknowledge receipt of the Customer Notification Letter by: 1. Confirm receipt of this notification letter by returning the enclosed Customer Response Form to Ventec within 7 days. 2. Upon receipt of the Customer Response Form, Ventec will arrange shipment of replacement device(s) or arrange repair of existing device(s). 3. Return the affected product to Ventec per instructions and shipping label provided with replacement device(s). Contact Ventec Customer Support at 844-MYVOCSN (844-698-6276) to discuss alternative arrangements, if necessary. If customers are no longer the owner of any of these devices, they need to complete an ownership transfer form at VentecLife.com/tracking so that the Recalling Firm can follow up with the current owner of the impacted device(s). If customers have any question
Quantity in commerce
1,934 devices (415 device that have not been updated)
Distribution
Distribution US nationwide, Hong Kong, and Japan
Product codes and lots
Catalog Number: PRT-00490-001 GTIN (Primary ID): 00855573007792/00855573007006 Serial Numbers: 114303; 114304; 113728; 113729; 113697; 114296; 113587; 113684; 113706; 113003; 112957; 112961; 112962; 112965; 112972; 112974; 112994; 112995; 112999; 113006; 113008; 113010; 113520; 113522; 113525; 113533; 113534; 113536; 113547; 113550; 113555; 113556; 113557; 113561; 113563; 113689; 113724; 114021; 114101; 114105; 114106; 114107; 114109; 114110; 114111; 114116; 114117; 114310; 114333; 114108; 112792; 112798; 114497; 114324; 114325; 114330; 114336; 114493; 114537; 113046; 113662; 113667; 113682; 113591; 113594; 113654; 113655; 113740; 114020; 114030; 114044; 114046; 114048; 114096; 114114; 114019; 114025; 114027; 114033; 114039; 114040; 114045; 114051; 114028; 113704; 113746; 113748; 113753; 113760; 113061; 113725; 113586; 113691; 114307; 114309; 113028; 113066; 113539; 113515; 113709; 114047; 112814; 112824; 112829; 112830; 112844; 112848; 112865; 112866; 112807; 112822; 112823; 112834; 112835; 112847; 112854; 112876; 122848; 113758; 114508; 114951; 114342; 114343; 114346; 114351; 114360; 114500; 114345; 114499; 114505; 112976; 113037; 113040; 113524; 114322; 114498; 114510; 114636; 114640; 114641; 114676; 114685; 114695; 114701; 114820; 114827; 114841; 114900; 114901; 114674; 114725; 114800; 114810; 114812; 114822; 114825; 113057; 113063; 112821; 112839; 112842; 112867; 112826; 112837; 112825; 112982; 112987; 113510; 113511; 113546; 113584; 113592; 113652; 113686; 113710; 113723; 113756; 113671; 113675; 113715; 114009; 114013; 114489; 114494; 113549; 113744; 114637; 114947; 112765; 112766; 112767; 112768; 112770; 112774; 112775; 112776; 112778; 112779; 112780; 112787; 112815; 112841; 112862; 112968; 112977; 113013; 113014; 113016; 113017; 113018; 113027; 113032; 113039; 113050; 113535; 113562; 113588; 113658; 113755; 114032; 114488; 114842; AARC0001; AARC002; AARC003; AARC004; AARC005; AARC006; AARC007; AARC008; AARC009; 114095; 113590;  Catalog Number: PRT-00490-100 GTIN (Primary ID): 00855573007761/00855573007204 Serial Numbers: 112929; 113598; 113233; 113238; 113239; 113241; 113243; 113244; 113245; 113603; 114193; 114201; 114255; 114266;  Catalog Number: PRT-00900-001 GTIN (Primary ID): 00855573007778/00855573007433 Serial Numbers: 113365; 113405; 113906; 113962; 113407; 113414; 113430; 113390; 113437; 113262; 113380; 113458; 113384; 113398; 113442; 113858; 113441; 113443; 113445; 113915; 113817; 113898; 113899; 113378; 113395; 113923; 113972; 113937; 113945; 113957; 113961; 113968; 113368; 113373; 113379; 113264; 113351; 113389; 113370; 113377; 113454; 113468; 113804; 113823; 113830; 113837; 113838; 113881; 113882; 113888; 113892; 113902; 113927; 113967; 113399;  Catalog Number: PRT-00900-100 GTIN (Primary ID): 00855573007785 Serial Numbers: 113096; 113300; 112923; 113107; 112877; 110392; 113143; 113183; 113274; 113323;  Catalog Number: PRT-01098-000 GTIN (Primary ID): 00855573007730 Serial Numbers: 114444; 114451; 114615; 114226; 114442; 114450; 114452; 114441; 114453;  Catalog Number: PRT-01100-000 GTIN (Primary ID): 00855573007747 Serial Numbers: 114556; 114591; 114634; 114771; 114779; 114603; 114606; 114667; 114710; 114713; 114737; 114739; 114559; 114783; 114869; 114576; 114587; 114364; 114369; 114374; 114387; 114391; 114560; 114568; 114764; 114776; 114787; 114849; 114549; 114569; 114705; 114562; 114355; 114372; 114405; 114550; 114594; 114601; 114652; 114659; 114661; 114662; 114358; 114383; 114386; 114389; 114390; 114530; 114540; 114401; 114422; 114424; 114548; 114670; 114714; 114850; 114414; 114417; 114554; 114561; 114861; 114862; 114543; 114786; 114789; 114912; 114917; 114851; 114628; 114211; 114542; 114528; 114531; 114483; 114750; 114643; 114644; 114748; 114926; 114991; 114891; 114892; 114894; 114357; 114409; 114604; 114413; 114653; 114654; 114734; 114754;  Catalog Number: PRT-01100-001 GTIN (Primary ID): 00855573007747 Serial Numbers: 114965; 114966; 114967;

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1902-2021
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1902-2021Class IIOngoingVoluntary: Firm initiated