BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARISA

    MDR report key: 1785779 · Received July 16, 2010

    Report

    Report Number
    9611530-2010-00038
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 7, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MFG BY ARJO HOSP EQUIPMENT (B)(4) WILL BE REPORTED BY US, THE LEGAL MFR, ARJO HOSP EQUIPMENT (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE USA, ARJO INC, (B)(4). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER (B)(6) 2010: THE PT WAS BEING LIFTED FROM THE BED TO ANOTHER BED. UPON CLEARING THE BED AND BEING MANOEUVERED AWAY, THE COMPLETE HANGER BAR AND JIB BECAME DETACHED FROM THE HOIST, FALLING TO THE FLOOR. CARE STAFF WERE ABLE TO ARREST THE FALL OF THE PT, SO POTENTIAL INJURIES WERE MINIMIZED. THE INJURY SUSTAINED WAS AS A RESULT OF THE PT'S ELBOW IMPACTING ON THE SIDE OF THE BED NOT THE HOIST. THE INJURY INCURRED WAS A SKIN TEAR ON THE ELBOW. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARISA LIFT, PATIENT, NON-AC- POWERED FSA ARJO HOSPITAL EQUIPMENT AB KGA0200

    Patients

    Seq Age Sex Outcome Treatment
    1