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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 Electrical /Electronic Property Problem (1198)
Patient Problem Insufficient Information (4580)
Event Type  Malfunction  
Manufacturer Narrative

Date of event: (b)(6) 2020. Date of report: 27aug2020.

 
Event Description

It was reported to philips that the device had a alarm power light emitting diode (led) failure. The device was not being used on a patient at the time of the event. There was no patient or user harm reported. The device was evaluated by the customer with assistance from a philips remote service engineer (rse). It was confirmed that the power switch overlay will need replacement. The customer's bio-med replaced the power switch overlay. The device passed performance verification testing and was placed back into service.

 
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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
melissa abbott
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key10463956
MDR Text Key205898230
Report Number2031642-2020-03011
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 USER FACILITY
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 08/07/2020
1 Device Was Involved in the Event
0 PatientS WERE 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
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/07/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/2010
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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