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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 Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

Date of event: (b)(6) 2020. Date of report: 14oct2020.

 
Event Description

The customer reported the unit shutdown when the patient was being transported from the room. The customer confirmed the reported unit shutdown when running on battery only while transporting the patient from the room. The unit showed battery not installed when the battery was installed. The customer indicated the district office found that the unit did not recognize the battery, installed a known working battery and vent then recognized battery and displayed battery information in the service mode/ventilator information screen. They validated that the power management board and related circuitry of the ventilator are operating properly. Battery replacement and final testing are in process. The device was reported to be in clinical use when patient was being transported from the room at the time the reported issue was discovered and the unit was swapped out; however, there was no reported patient or user harm.

 
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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
carlsbad CA
Manufacturer Contact
bill cole
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key10681333
MDR Text Key213467566
Report Number2031642-2020-03730
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
Type of Report Initial
Report Date 09/25/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/14/2020
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?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/25/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/26/2016
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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