BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTIFLEX III CPM

    MDR report key: 1743177 · Received June 28, 2010

    Report

    Report Number
    1022819-2010-00011
    Event Type
    Other
    Date Received
    June 28, 2010
    Date of Event
    April 20, 2010
    Report Date
    June 28, 2010
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    BXB
    PMA / PMN Number
    K841674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT FAILED INITIAL ELECTRICAL SAFETY TESTING. THE IEC CONNECTOR WAS PULLED OUT OF ITS RECEPTACLE AND MISSING. IT APPEARED TO HAVE BEEN PHYSICALLY PULLED OUT OF THE ENCLOSURE. AFTER REPLACING THE UNITS GROUNDING TESTED GOOD WITH ONLY .6 OHMS FROM FRAME TO PLUG. CONTINUED TO TEST THE UNIT AND THE UNIT PASSED ALL THE TESTS. CONCLUSION: THE UNITS IEC CONNECTOR FAILED TO REMAIN INTACT. IT LOOKED TO HAVE BEEN FORCEFULLY PULLED OUT. IF THE GROUND CONNECTOR MADE CONTACT WITH ONE OF THE POWER WIRES IT WOULD PRESENT A FIRE HAZARD. IT WILL BE REPLACED BEFORE RETURNING TO THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER ((B)(6) REGIONAL MEDICAL CENTER) COMPLAINED THAT POWER CORD PLUG-IN ON UNIT PULLED OUT OF UNIT. THE UNIT WAS NOT IN USE AT THE TIME OF DISCOVERY. NO INJURY OCCURRED AND NO PATIENT WAS INVOLVED. DEVICE HAS MALFUNCTIONED AND THE DEVICE OR A SIMILAR DEVICE MARKETED BY THE MANUFACTURER WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLEX III CPM BXB CHATTANOOGA GROUP 2090

    Patients

    Seq Age Sex Outcome Treatment
    1