BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI MOVE (AHE)

    MDR report key: 1981081 · Received January 27, 2011

    Report

    Report Number
    9611530-2011-00009
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    October 21, 2010
    Report Date
    January 17, 2011
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO EXEMPTION NO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MFG BY ARJO HOSP EQUIPMENT AB IN (B)(4) WILL BE REPORTED BY US, THE LEGAL MFR, ARJO HOSP EQUIPMENT AB IN (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN (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 2011-(B)(6): CAREGIVER WAS CHANGED BATTERY OVER TO CHARGE. CHARGER ON FLOOR, LIFTED CHARGER TO CONNECT THE DISCHARGED BATTERY, THE CASING OF THE CHARGER WAS OPEN, EXPOSING SOME WIRES. THE CAREGIVER RECEIVED AN ELECTRIC SHOCK CAUSING MINOR BURNS TO PALM OF LEFT HAND. NOT REPORTED TO ARJOHUNTLEIGH UNTIL (B)(6) 2011. BATTERY CHARGER COULD NOT BE INSPECTED AS IT WAS REMOVED BY 3RD PARTY SERVICE AGENT - HAS BEEN REPLACED BY 3RD PARTY CHARGER. ORIGINAL REPORT NOT ATTENDED BY ARJOHUNTLEIGH. SEE IDF AND ASSOCIATED DOCUMENTS, PHOTOGRAPHS ATTACHED. THIS INCIDENT WAS REPORTED BY NIAIC AND THEY HAVE REQUESTED INFO. (B)(4).

    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 OTHER

    Patients

    Seq Age Sex Outcome Treatment
    1