BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPO

    MDR report key: 1266222 · Received December 12, 2008

    Report

    Report Number
    9681684-2008-00032
    Event Type
    Injury
    Date Received
    December 12, 2008
    Date of Event
    October 16, 2008
    Report Date
    December 12, 2008
    Manufacturer
    BHM MEDICAL, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIFT WAS INSPECTED BY AN ARJO INVESTIGATOR AND WAS FOUND TO BE IN GOOD WORKING CONDITION WITH SOME MINOR SCRATCHES. IT WAS ALSO NOTED THAT THE LIFT HAD SOME NON-OEM PADDING ON THE HANGER BAR. THE PADDING WAS REMOVED AFTER THE INCIDENT. THE FACILITY WAS NOT ABLE TO LOCATE THE SLING INVOLVED IN THE INCIDENT FOR THE INVESTIGATOR TO EXAMINE. THE TYPE OF SLING IS UNKNOWN. THE MANUFACTURER IS UNABLE TO COME TO ANY CONCLUSION REGARDING THE CAUSE OF THE EVENT, AS IT IS NOT KNOWN WHAT SLING WAS USED. IT IS POSSIBLE THE SLING USED WAS UNSUITED FOR USE ON A TEMPO. A SLING SUITED FOR THE TEMPO AND USED IN ACCORDANCE TO THE TEMPO OPERATING AND PRODUCT CARE INSTRUCTIONS IS UNLIKELY TO DETACH DURING TRANSFER. THE MANUFACTURER STRONGLY RECOMMENDS STAFF BE RETRAINED TO THE LIFTER OPI.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT TWO STAFF MEMBERS WERE USING A TEMPO LIFT AND AN UNKNOWN SLING TO TRANSFER A RESIDENT FROM THE BED TO A WHEELCHAIR. IT IS INDICATED THAT AS SOON AS THE RESIDENT WAS LIFTED CLEAR FROM HER SPECIAL "BOLSTER" MATTRESS, THE LEFT SIDE OF THE SLING LEG ATTACHMENT BECAME UNDONE. THE RESIDENT SLIPPED OUT, FELL TO THE GROUND, AND HIT HER HEAD ON THE LEG OF THE LIFT, SUSTAINING A CUT TO THE BACK OF THE HEAD. THE INJURY WAS TREATED WITH A PRESSURE DRESSING, ICE AND BACITRACIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPO PATIENT LIFT FSA BHM MEDICAL, INC. KPAXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention