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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 Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2019.Date of report: 07oct2019.The manufacturer¿s international service technician replaced the pm pcba and the problem was resolved.The ventilator successfully passed performance specification testing after the repair was completed.
 
Event Description
It was reported that a component on the pm pcba (power management printed circuit board assembly) was identified to be damaged during periodic maintenance.There was no patient involvement.
 
Manufacturer Narrative
Date rec'd by mfr: 21nov2019.The replaced power management printed circuit board assembly was returned and failure investigation was performed on 21-nov-2019.It was confirmed that the reported damaged component was missing from the board.No errors were identified before or after replacing the missing component during testing.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 Key9161854
MDR Text Key192168011
Report Number2031642-2019-09985
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 company representative,foreig
Type of Report Initial,Followup
Report Date 10/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2019
Was the Report Sent to FDA? No
Date Manufacturer Received10/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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