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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); Insufficient Cooling (1130)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Date of event: (b)(6) 2020. Date of report: 20aug2020.

 
Event Description

It was reported to philips by the customer (biomed) that the v60 ventilator displayed an over temperature error. The device was not being used on a patient at the time of the event. There was no adverse event to the patient or user as a result of this event. The device was evaluated by the customer with assistance from a philips remote service engineer (rse). The rse advised the customer to verify the v60 cooling fan is running, and to verify the air inlet filter is clean. The rse also asked the biomed to check the significant event log for over temperature errors, however the biomed is unable to locate any temperature errors in the log. A philips field service engineer (fse) was dispatched to the customer site. The reported issue was confirmed and traced to a faulty blower. The blower assembly was replaced to resolve the reported issue.

 
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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 Key10434853
MDR Text Key204198862
Report Number2031642-2020-02880
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 07/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/20/2020
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? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/29/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/13/2013
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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