BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPID RESPONSE HUT TABLE

    MDR report key: 2507465 · Received March 2, 2012

    Report

    Report Number
    1932056-2012-00001
    Event Type
    Other
    Date Received
    March 2, 2012
    Date of Event
    February 28, 2012
    Report Date
    February 29, 2012
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    LGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION UNCOVERED THAT THE USER WAS ATTEMPTING TO PLUG THE PRODUCT INTO THE 120 VAC UTILITY POWER WHILE THE POWER SWITCH IS IN THE "ON" POSITION. BECAUSE THERE IS A TRANSFORMER IN THE UNIT, THERE IS A MOMENTARY SPIKE IN THE CURRENT DRAW AND THEN LEVELS OUT. THE COMPANY ADVISED THE CUSTOMER TO MAKE SURE THAT THE PRODUCT'S POWER SWITCH IS IN THE "OFF" POSITION BEFORE CONNECTING IT TO UTILITY POWER. THE COMPANY ALSO OPENED CAPA (B)(4). UPON REVIEW OF PRODUCT LABELING IT WAS DISCOVERED THAT INSTRUCTIONS FOR PROPERLY CONNECTING THE PRODUCT TO UTILITY POWER ARE MISSING FROM THE OWNER'S MANUAL. THE COMPANY WILL UPDATE THE MANUAL WITH THE PROPER INSTRUCTIONS/WARNING FOR CONNECTING THE UNIT TO UTILITY POWER. THE COMPANY WILL SEND THE MANUAL UPDATE TO ALL NINE (9) CUSTOMERS WHO HAVE PURCHASED THE PRODUCT.

    Description of Event or Problem · 1

    AS THE NURSE PLUGGED THE PRODUCT INTO 120 VAC UTILITY POWER, THERE WAS A MOMENTARY SPARK BETWEEN THE OUTLET AND THE PLUG AND THE NURSE RECEIVED A MINOR SHOCK, BUT NO INJURY FROM THE SPARK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID RESPONSE HUT TABLE RAPID RESPONSE HUT TABLE LGX MEDICAL POSITIONING, INC. 1217

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other