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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); Mechanical Problem (1384); Failure to Power Up (1476); Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Event date: (b)(6) 2018. Date of report: 9oct2018. Customer swapped the power management (pm) board with another unit and it corrected the issue. Customer swapped pm board back to other unit. The customer replaced the pm board to resolve the reported issue. No parts returned to failure investigation; therefore, the root cause of the reported issue could not be determined.

 
Event Description

Customer contacted technical support (ts) stating that unit did not power up and had error code messages of 35v supply failed, backup alarm failed, auxiliary alarm supply failed, and blower stalled. The customer reported there was no patient involvement. The event date was not specified; estimate used.

 
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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)
RICA
2271 cosmos court
carlsbad CA 92011
Manufacturer Contact
lisa cardenas
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key7947879
MDR Text Key123262045
Report Number2031642-2018-02137
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
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 09/17/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/09/2018
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 Received09/17/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/27/2011
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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