BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2023050-2007-00009

    MDR report key: 972399 · Received March 9, 2007

    Report

    Report Number
    2023050-2007-00009
    Event Type
    Malfunction
    Date Received
    March 9, 2007
    Report Date
    March 9, 2007
    Product Code
    CBK
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE COMPLAINT WAS DUPLICATED. THE REMOTE ALARM HAD BECOME DISCONNECTED FROM PCB1840A; HOWEVER, THE REASON THE ALARM BECAME DISCONNECTED WAS BECAUSE THE NUT THAT FASTENS THE ALARM TO THE CASE HAD BECOME LOOSE. THE REMOTE ALARM WAS CONNECTED TO PCB1840A, AND THE NUT TO THE REMOTE ALARM WAS TIGHTENED TO NMI MANUFACTURING STANDARDS. THE GDU PASSED ALL STANDARD OPERATING TESTS.

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED TO NMI BY THE SAME USER FACILITY ON JAN 10TH. AT THAT TIME, NMI DECIDED NOT TO SUBMIT MDR BECAUSE INFO THAT NMI REC'D ON JAN 10TH DID NOT REASONABLY SUGGEST THAT THE MALFUNCTION WOULD LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. UPON RECEIPT OF MDR ON FEB 27TH, WHICH INCLUDE ADDITIONAL INFO, NMI DETERMINED THE CASE TO BE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBK GDU1800

    Patients

    Seq Age Sex Outcome Treatment
    1