BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11826197 · Received May 14, 2021

    Report

    Report Number
    2031642-2021-03728
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 16, 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:(B)(6)2021 THE REMOTE SERVICE ENGINEER REPORTED THAT THE CUSTOMER DECLINED PHILIPS SUPPORT. IT IS UNKNOWN WHETHER THE BATTERY WAS REPLACED BY THE CUSTOMER. NO OTHER ANOMALIES WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A VENTILATOR EXPERIENCED A POWER FAULT. THE DEVICE WAS EVALUATED BY THE CUSTOMER AND A PHILIPS REMOTE SERVICE ENGINEER (RSE). THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT OR USER HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722566 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V60 VENT, CHINA OPT: CFLEX, AVAPS 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1