BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRAVO HANGERS

    MDR report key: 1276823 · Received December 31, 2008

    Report

    Report Number
    9681684-2008-00044
    Event Type
    Death
    Date Received
    December 31, 2008
    Report Date
    December 29, 2008
    Manufacturer
    BHM MEDICAL, INC
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL DETAILS OR INFO HAVE BEEN PROVIDED BY THE FACILITY EXCEPT THAT THE LIFT HAS BEEN REMOVED FROM SERVICE. NO INVESTIGATION WAS CONDUCTED BY ARJO. BASED ON THE INFO PROVIDED, THE MFR CONCLUDES THAT THE INCIDENT IS DUE TO A USER ERROR. NO DETAIL OR INFO WAS PROVIDED BY THE FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT DIED ALLEGEDLY AS A RESULT OF A BRAVO RETURNING TO CHARGE WHILE ONE LOOP SLING REMAINED HOOKED TO THE DEVICE. THE PT ROLLED OUT AND FELL ONTO THE FLOOR AND DIED. THE USER CLAIMED HE TOOK THE LOOP BACK WHILE THE UNIT WAS RETURNING TO CHARGE. THE DATE OF DEATH IS UNK. THE DATE OF THE EVENT IS UNK. IT WAS INITIALLY REPORTED TO THE SALES COMPANY ON 09/02/2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO HANGERS PATIENT LIFT HANGER FNG BHM MEDICAL, INC LTXXXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1 Death