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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 Failure to Zero (1683)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2019.Date of report: 12dec2019.
 
Event Description
It was reported that the ventilator produced a diagnostic code related to machine pressure sensor autozero failure.The ventilator was being used at the time of the reported event, however, there was no patient harm.The manufacturer¿s international service technician evaluated the ventilator and determined that the data acquisition printed circuit board assembly (da pcba) required replacement.The service technician replaced the da pcba and the problem was resolved.
 
Manufacturer Narrative
Date rec¿d by mfr: 16dec2019, date of report : 19dec2019.The customer did not provide the patient's information.There was no report of medical intervention required as a result of this event.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.
 
Manufacturer Narrative
G4: 13feb2020 b4: (b)(6) 2020.The replaced data acquisition printed circuit board assembly (da pcba) was returned for failure analysis.The da pcba was tested and no failures were identified.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 Key9459348
MDR Text Key193683853
Report Number2031642-2019-10832
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,Followup
Report Date 11/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
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? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/27/2019
Initial Date FDA Received12/12/2019
Supplement Dates Manufacturer Received11/27/2019
11/27/2019
Supplement Dates FDA Received12/19/2019
02/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
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