BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, MEDICAL POWER SUPPLY

    MDR report key: 5004682 · Received August 14, 2015

    Report

    Report Number
    0002936485-2015-00734
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 20, 2015
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    FWB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION: NO VISIBLE DAMAGE TO THE CONNECTOR PINS, WIRES AND POWER BRICK. FUNCTIONAL INSPECTION : THE PKG, MEDICAL POWER SUPPLY WAS TESTED WITH A KNOWN WORKING VISION PRO MONITOR AND POWER CHORD. THERE WAS NO POWER COMING OUT OF THE PKG, MEDICAL POWER SUPPLY. PROBABLE ROOT CAUSE/S COULD BE A BAD POWER SUPPLY DUE TO A BAD COMPONENT INSIDE THE POWER BRICK. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION: NO VISIBLE DAMAGE TO THE CONNECTOR PINS, WIRES AND POWER BRICK. FUNCTIONAL INSPECTION : THE PKG, MEDICAL POWER SUPPLY WAS TESTED WITH A KNOWN WORKING VISION PRO MONITOR AND POWER CHORD. THERE WAS NO POWER COMING OUT OF THE PKG, MEDICAL POWER SUPPLY. PROBABLE ROOT CAUSE/S COULD BE A BAD POWER SUPPLY DUE TO A BAD COMPONENT INSIDE THE POWER BRICK. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MEDICAL POWER SUPPLY GOT DAMAGED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MEDICAL POWER SUPPLY GOT DAMAGED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MEDICAL POWER SUPPLY GOT DAMAGED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539888 PKG, MEDICAL POWER SUPPLY CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO FWB STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1