BEUDAMED
    FDA Adverse Event Other Summary report: N

    SARA 3000

    MDR report key: 2609704 · Received November 11, 2009

    Report

    Report Number
    3004468271-2009-00021
    Event Type
    Other
    Date Received
    November 11, 2009
    Date of Event
    September 24, 2009
    Manufacturer
    MEDIBO N.V.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL ALSO BE SUBMITTED WHEN THE MFR CONCLUDES THEIR INVESTIGATION.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE WIFE WANTED TO RAISE UP HER HUSBAND WITH THE LIFT. THEY HAD DONE SO OFTEN BEFORE. THIS TIME IT WENT WRONG AND THE HUSBAND SLIPPED. HE LANDED ON THE FLOOR AND, IN THE PROCESS, CUT OPEN HIS LEGS ON THE LEGS OF THE LIFT. THE HUSBAND WAS IN PAIN. THE WIFE COULD NOT GET HER HUSBAND BACK INTO BED AND CALLED THE POLICE FOR HELP. THE POLICE PERSONS DID NOT WANT TO LIFT THE HUSBAND ONTO THE BED; AN AMBULANCE WAS CALLED. THE AMBULANCE STAFF AND POLICE PERSONS LIFTED THE HUSBAND BACK ONTO THE BED. THE AMBULANCE STAFF BANDAGED THE LEGS OF THE HUSBAND. DURING THE INTERVIEW, THE WIFE STATED THERE WERE NO INSTRUCTIONS FOR THE USE OF THE LIFT. SHE INDICATED THAT SHE WOULD HAVE WANTED THESE BECAUSE SHE FEELS IT WOULD HAVE INDICATED TO HER THAT THE STRAPS SHOULD HAVE BEEN IN PLACE AROUND THE LEGS. ACCORDING TO THE WIFE, IF THESE WOULD HAVE BEEN TIGHTLY IN PLACE, THE HUSBAND WOULD NOT HAVE DROPPED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA 3000 LIFT, PATIENT, NON-AC-POWERED FSA MEDIBO N.V. HEA0002

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other