BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI MOVE (AHE)

    MDR report key: 1728915 · Received June 2, 2010

    Report

    Report Number
    9611530-2010-00026
    Event Type
    Malfunction
    Date Received
    June 2, 2010
    Date of Event
    May 24, 2010
    Report Date
    May 24, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTING ACCORDING TO EXEMPTION (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT AB IN (B)(4) WILL BE REPORTED BY US, THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT AB IN (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 MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER (B)(6)2010: MILD ELECTRIC SHOCK FROM BATTERY CHARGER (CASE SEPARATED). CHARGER LOOKED IN GOOD CONDITION; HOWEVER, IT HAD A WHITE STICKY LABEL DOWN EITHER SIDE TO HOLD THE 2 HALVES TOGETHER. FUNCTION TEST: ALL FUNCTIONS OF THE HOIST WORKING CORRECTLY. UNABLE TO FUNCTION TEST CHARGER AS IT HAD BEEN REMOVED FROM SITE PRIOR TO VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI MOVE (AHE) LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB KMB*

    Patients

    Seq Age Sex Outcome Treatment
    1