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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  
Manufacturer Narrative

Date of event: (b)(6) 2018. Date of report: 19sep2019. The manufacturer¿s international service technician confirmed the reported led issue. The manufacturer¿s international service technician replaced the power switch overlay to address the reported problem. The unit was checked overall, run in tested, cleaned and functionally tested and no abnormality was confirmed. This mdr has been reassessed as reportable after a request from the fda on march 1, 2019 to review complaints from 29 nov 2017 to 29 nov 2018. As this has been reassessed, it will appear to be a late mdr.

 
Event Description

During periodic maintenance, the manufacturer¿s international service technician reported the green power led did not light. The manufacturer¿s international service technician reported 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 (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
melissa abbott
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key9096155
MDR Text Key164900643
Report Number2031642-2019-09736
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 COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 11/14/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/19/2019
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?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/26/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/08/2013
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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