BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMOTE ALARM

    MDR report key: 3040203 · Received April 3, 2013

    Report

    Report Number
    2518422-2013-00439
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K862212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REMOTE ALARM WAS EVALUATED BY THE MFR. THE MFR FOUND THE DEVICE TO CONTINUOUSLY ALARM. THE TECHNICIAN FOUND A BROKEN BATTERY CONNECTOR WIRE, CAUSING THE DEVICE TO NOT OPERATE ON BATTERY POWER. THE DEVICE WOULD OPERATE AND ALARM PROPERLY ON AC POWER. THE BATTERY CONNECTOR WAS REPLACED TO CORRECT THE ISSUE. IF THE REMOTE ALARM (OPTIONAL ACCESSORY) WAS USED IN CONJUNCTION WITH A VENTILATOR, THE VENTILATOR WOULD CONTINUE TO PROVIDE THERAPY AND AUDIBLY ALARM FOR PATIENT EVENTS. WAITING FOR APPROVAL OF ESTIMATE.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFORMATION ALLEGING A REMOTE ALARM HAD NO SIGNAL. THE DEVICE WAS NOT IN PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136293 REMOTE ALARM VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. R34003 R34003

    Patients

    Seq Age Sex Outcome Treatment
    1