BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11950657 · Received June 7, 2021

    Report

    Report Number
    2031642-2021-03979
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 18, 2021
    Product Code
    MNT
    UDI-DI
    00884838025776
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G5:510(K)#: K102985. B4:10JUL2021. THE SERVICE ENGINEER (SE) CONFIRMED THE REPORTED FAILURE. THE BATTERY WAS LESS THAN 5 YEARS OLD. THE (SE) REPLACED THE BATTERY TO RESOLVE THE ISSUE. THE BATTERY RETURNED TO NORMAL POWER SUPPLY. THE UNIT WAS TESTED AND IT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A VENTILATOR BATTERY FAULT. THE DEVICE WAS NOT IN CLINICAL USE. NO PATIENT OR USER HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843951 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V60 VENT, CHINA OPT: CFLEX, AVAPS 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1