BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS CONSOLE

    MDR report key: 2082074 · Received April 26, 2011

    Report

    Report Number
    1811755-2011-01423
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    K943589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS THE DEVICE WOULD NOT POWER UP WHEN PLUGGED IN. UPON DISASSEMBLY OF THE DEVICE, THE POWER ENTRY ASSEMBLY, LIQUID CRYSTAL DISPLAY, TOUCH SCREEN GASKET AND OTHER COMPONENT PARTS WERE DAMAGED. THE DAMAGED PARTS WERE REPLACED AND THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE TPS CORE CONSOLE WAS SENT IN FOR REPAIR BECAUSE IT LOST POWER DURING A PROCEDURE AND CAUSED A 20 MINUTE TO 30 MINUTE DELAY IN PROCEDURE. NO ADVERSE EVENT WAS REPORTED, HOWEVER, THE PT RECEIVED ADD'L ANESTHESIA WHILE A REPLACEMENT CONSOLE WAS BEING OBTAINED FROM ANOTHER FACILITY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER CONSOLE WITHOUT ANY FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPS CONSOLE HWE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK