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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS RESPIRONICS - CT V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

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PHILIPS RESPIRONICS - CT V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE Back to Search Results
Model Number V60
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Event Description

The customer reported that the ventilator alarmed with 35volt failure. The customer reported there was no patient involvement.

 
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Brand NameV60 VENTILATOR
Type of DeviceVENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
Manufacturer (Section D)
PHILIPS RESPIRONICS - CT
5 technology drive
wallingford CT 06492
Manufacturer Contact
robert corning
5 technology drive
wallingford, CT 06492
MDR Report Key4862560
MDR Text Key5849681
Report Number1219324-2015-00002
Device Sequence Number1
Product Code MNT
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility
Reporter Occupation
Type of Report Initial
Report Date 06/15/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/23/2015
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
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/15/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/09/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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