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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 Electrical /Electronic Property Problem (1198); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The international manufacturer's service technician reported a capacitor on the central processing unit pcba had shorted. There was no patient involvement.

 
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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 Key5060499
MDR Text Key25810280
Report Number2031642-2015-01737
Device Sequence Number1
Product Code MNT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial
Report Date 06/22/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/08/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Device MODEL NumberV60
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/17/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/18/2014
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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