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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 Problems Blower (738); Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Event Description

It was reported that the ventilator was alarming high blower temperature. There was no patient involvement at the time of the event occurred.

 
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Brand NameV60 VENTILATOR
Type of DeviceVENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC
2271 cosmos court
carlsbad CA 92011
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
robert corning
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key7389052
MDR Text Key104254623
Report Number2031642-2018-00680
Device Sequence Number1
Product Code MNT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 03/05/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/02/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberV60
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/05/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/22/2013
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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