BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 14755412 · Received June 21, 2022

    Report

    Report Number
    2031642-2022-01645
    Event Type
    Malfunction
    Date Received
    June 21, 2022
    Date of Event
    June 14, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838025776
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6).

    Additional Manufacturer Narrative · 0

    PER AUTHORIZED SERVICE PERSONNEL (ASP) THE REPORTED PROBLEM OF ALARM OVP CIRCUIT FAILURE WAS CONFIRMED. THE (ASP) REPLACED THE MOTOR CONTROL (MC) BOARD; TEST AND INSPECTION WERE PERFORMED AND PASSED. THE DEVICE RETURNED TO FULL FUNCTIONALITY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE UNIT FAILED WITH OVER VOLTAGE PROTECTION (OVP) FAULT ALARM. THE CUSTOMER REPORTED THAT THE UNIT WAS NOT IN USE ON PATIENT. THE CUSTOMER CONTACTED PRODUCT SUPPORT AND REQUESTED FOR SERVICE REPAIR. 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
    1756625 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 VENT, CHINA OPT: CFLEX, AVAPS 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown