BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 1023651 · Received April 1, 2008

    Report

    Report Number
    2031642-2008-00077
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 2 OF THEIR REMOTE ALARM CABLES HAD THE CABLES WIRING PULLING AWAY FROM THE CABLE PLUG. BOTH PRODUCT PROBLEMS WERE REPORTED IN 2008. THE CUSTOMER REPORTED WHEN THE CABLES WERE PLACED INTO THE REMOTE ALARM JACK OF A VENTILATOR AND A VENTILATOR ALARM ACTIVATED, THE FACILITY REMOTE NURSE CALL DID NOT ALARM. THE CUSTOMER REPORTED THE CABLES WERE NOT BEING USED WHILE ON A PATIENT; THEREFORE, THERE WAS NO PATIENT HARM OR INVOLVEMENT. THE CUSTOMER ORDERED REPLACEMENT CABLES AND WAS REQUESTED TO SEND THE DAMAGED CABLES BACK TO THE MANUFACTURING FACILITY FOR FAILURE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA CABLE, REMOTE ALARM, ALARM STATE-CLOSED CBK RESPIRONICS CALIFORNIA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA