BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO, BASIC & SHOWER TROLLEY

    MDR report key: 1942815 · Received December 20, 2010

    Report

    Report Number
    9611530-2010-00127
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE 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 (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 ON (B)(6) 2010: SERIAL # OF STRETCHER IS (B)(4). SOME SCREWS WERE LOOSEN OUT AND THE STRETCHER DETACHED FROM THE CHASSIS SUDDENLY WITH PT. LUCKILY THE NURSE HELD THE STRETCHER AND THE PT DIDN'T FALL TO THE FLOOR. ANOTHER SIDE OF HOLDER HAS 1 SCREW LOOSEN AND LOST. THIS BED WAS USED ONLY 2 YEARS AND THE CONCERTO OVERALL CONDITION WAS STILL GOOD. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO, BASIC & SHOWER TROLLEY LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB BAB1000-01

    Patients

    Seq Age Sex Outcome Treatment
    1