BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI MOVE (AHE)

    MDR report key: 1948329 · Received December 15, 2010

    Report

    Report Number
    9611530-2010-00126
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    January 1, 2010
    Report Date
    December 3, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO EXEMPTION NO (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 (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER 2010-(B)(6): US CUSTOMER COMPLAINT - BATTERY CHARGER AND BATTERY SMOKED UP AND BURNED A HOLE IN THE CHARGER. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1