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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 Align (2522)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of rpeort: 28aug2020.
 
Event Description
It was reported to philips that the device's touchscreen wasn't reacting and was misaligned.The device was not being used on a patient at the time of the event.There was no patient or user harm reported.
 
Manufacturer Narrative
G4: 18nov2020, b4: 19nov2020.A philips service engineer (se) evaluated the device and confirmed the issue.The se determined that the touchscreen needed replacement.The customer declined philips service to repair the device and returned back to the customer unrepaired.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 Key10469058
MDR Text Key206151345
Report Number2031642-2020-03020
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 08/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberV60
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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