BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 6157482 · Received December 9, 2016

    Report

    Report Number
    2031642-2016-03396
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Report Date
    November 15, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PHILIPS CONTACTED CUSTOMER REQUESTING FOR REPAIR DETAILS, PATIENT AND EVENT DATE. THE PRODUCT SUPPORT CALLED CUSTOMER AND LEFT DETAILED MESSAGE ADVISING CUSTOMER TO SWAP BATTERY ON THIS UNIT AND RE-TEST. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION REGARDING THE DEVICE REPAIR INFORMATION. TO DATE NO FURTHER DETAILS HAVE BEEN RECEIVED. THE SERVICE HISTORY RECORD WAS REVIEWED AND NO REPAIR INFORMATION WAS FOUND.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DISPLAY AND VENTILATOR WILL NOT TURNED OFF. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON PATIENT, BUT THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812277 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1