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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE Back to Search Results
Model Number V60
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2019.Date of report: 12/06/2019.
 
Event Description
The customer reported the flow offset was too large.There was no patient involvement.
 
Manufacturer Narrative
Pma/510k : 09dec2019, date of report: 30dec2019.After further investigation.This issue is not reportable.The air flow accuracy test is performed as part of the pvt (performance verification test), which is always performed prior to putting the ventilator into use on a patient.There is no risk of patient harm because the unit would not be put into use on a patient if it fails any portion of the pvt.This event is unlikely to cause or contribute to death or serious injury.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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Brand Name
V60 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC
2271 cosmos court
carlsbad CA 92011
MDR Report Key9427728
MDR Text Key184503920
Report Number2031642-2019-10761
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
PMA/PMN Number
K082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 11/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberV60
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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