BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 14756550 · Received June 21, 2022

    Report

    Report Number
    2031642-2022-01649
    Event Type
    Malfunction
    Date Received
    June 21, 2022
    Date of Event
    June 3, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6).

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO GOOD FAITH EFFORT (GFE) INTERNATIONAL FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT DEVICE WAS OUTSIDE OF CLINICAL USE. NO PATIENT OR USER HARM NOTED. FSE DID NOT CHECK UNIT FOR ALARMING AND REPORTED THAT THE UNIT WAS OVERDUE FOR SERVICE AND BATTERY REPLACEMENT. THE BATTERY IS OLDER THAN 5 YEARS BASED ON THE DATE OF MANUFACTURING THAT IS 26 APRIL 2017. BATTERY HAS NOT BE REPLACED YET. THEY ARE AWAITING THEIR GAS BANK TO BE INSTALLED AT THEIR REPAIR BENCH FOR THEM TO DO THE PERIODIC MAINTENANCE (PM) ON THE UNIT.

    Description of Event or Problem · 0

    A BATTERY FAULT WAS REPORTED. PATIENT/USER INVOLVEMENT IS UNKNOWN. NO HARM WAS REPORTED. FURTHER INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1756669 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown