BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVESCAN WAVEFRONT SYSTEM

    MDR report key: 1932728 · Received November 24, 2010

    Report

    Report Number
    3006695864-2010-00133
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HKO
    PMA / PMN Number
    K000327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AMO FIELD SERVICE ENGINEER INSPECTED THE VIDEO BOARD FROM THE WAVESCAN COMPUTER AND FOUND THE CAPACITORS HAD BURNT AND WERE THE CAUSE OF THE BOARD FAILURE. NO FURTHER INFO IS AVAILABLE.

    Description of Event or Problem · 1

    AN AMO FIELD SERVICE TECH REPORTED THAT WHILE INSPECTING THE WAVESCAN AT THE CUSTOMER LOCATION FOR A REPORT OF NON OPERATION, HE NOTICED VISIBLE SMOKE MARKS ON THE BACK OF THE COMPUTER UNIT. INTERNALLY, HE FOUND THE VIDEO BOARD WAS BURNT AT THE CORNER AND BOTTOM AND THE MOTHERBOARD HAD EVIDENCE OF MELTING AT THE BUS SLOT. THE CUSTOMER INDICATED THAT THE SMOKE ALARM HAD BEEN TRIGGERED, HOWEVER, THEY DID NOT ASSOCIATE THIS WITH THE WAVESCAN. NO ONE AT THE CUSTOMER LOCATION REPORTED WITNESSING THE WAVESCAN SMOKING. THE FIELD SERVICE ENGINEER INDICATED THAT THERE WAS A SMELL OF BURNT ELECTRONICS IN THE ROOM WHERE THE EQUIPMENT WAS INSTALLED. AMO BELIEVES THAT THE WAVESCAN PCB COMPONENT FAILING RESULTED IN ENOUGH SMOKE BEING EMITTED TO HAVE TRIGGERED THE SMOKE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAVESCAN WAVEFRONT SYSTEM HKO AMO MANUFACTURING USA, LLC WS1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1