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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 No Patient Involvement (2645)
Event Type  Malfunction  
Event Description

During failure investigation the failure investigation engineer found that c187 on the mc board is shorted which took out the 12 volt signal. The customer reported the device was not in use on patient.

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

Visual inspection showed no signs of damage or contamination. The mc board, cpu pcba, and gds system will be installed into the fi test ventilator. There will be an attempt to boot into the normal ventilation mode. The 12 volt supply will be verified. The no power state was traced to the mc board which had a shorted cap at c187. The mc board will be reinstalled into the fi test ventilator with the customer returned cpu pcba and gds system still installed in the unit. The diagnostic mode will be entered and the drpt report will be downloaded and reviewed for errors. The mc board, cpu pcba, and gds system will be allowed to run for an extended period to verify the unit remains operational with no errors.

 
Event Description

During failure investigation, the failure investigation engineer found that c187 on the mc board is shorted which took out the 12 volt signal. The customer reported the device was not in use on patient.

 
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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 Contact
phyllis mccarthy
2271 cosmos court
carlsbad, CA 92011
MDR Report Key4920659
MDR Text Key21767036
Report Number2031642-2015-01321
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,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/08/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/17/2015
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? Device Returned To Manufacturer
Date Returned to Manufacturer11/20/2014
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/06/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/21/2013
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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