BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALIBU MK3 BATH

    MDR report key: 1802415 · Received August 5, 2010

    Report

    Report Number
    9611530-2010-00051
    Event Type
    Malfunction
    Date Received
    August 5, 2010
    Date of Event
    May 31, 2010
    Report Date
    August 3, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 THE (B)(4). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION. TRACK WISE ID.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER ON THE 2010-(B)(6): BATHING TRANSFER SEAT BECAME DETACHED FROM BATH LIFTING MAST DURING RAISING. RESULTING IN PT AND SEAT FALLING TO FLOOR. INJURIES UNK. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALIBU MK3 BATH ASSISTED BATH ILJ ARJO HOSPITAL EQUIPMENT AB AJL1334-GB

    Patients

    Seq Age Sex Outcome Treatment
    1