BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11611550 · Received April 2, 2021

    Report

    Report Number
    2031642-2021-03237
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    March 4, 2021
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4:20MAY2021. G5:510K: K102985. B4:16JUN2021. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ON THE REPAIR AND OPERATIONAL STATUS OF THE DEVICE THAT HAS BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR HAD AN ERROR MESSAGE ON BATTERY. ADDITIONAL INFORMATION ABOUT THE EVENT HAS BEEN REQUESTED. ALTHOUGH REQUESTED, IT IS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE VENTILATOR AT THE TIME OF THE EVENT. NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507525 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1