BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINSTREL

    MDR report key: 2240951 · Received September 6, 2011

    Report

    Report Number
    3004468271-2011-00036
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    January 1, 2011
    Report Date
    August 5, 2011
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT IS BEING FILED UNDER (B)(4) BY ARJOHUNTLEIGH ((B)(4)) ON BEHALF OF THE MFR MEDIBO (B)(4). ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER CONTACTED THE ARJOHUNTLEIGH - (B)(4) TECHNICIAN BECAUSE THE ARM OF THE MINSTREL FELL DOWN (THE CONNECTION BETWEEN THE ARM AND THE MAST WAS FOUND TO BE COMPLETELY CRACKED). IT IS UNK IF A PT WAS ON THE LIFTER WHEN THE EVENT OCCURRED AS THE FACILITY HAS NOT RELEASED ANY OTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINSTREL PASSIVE FLOOR LIFT FSA MEDIBO MEDICAL PRODUCTS NV

    Patients

    Seq Age Sex Outcome Treatment
    1 Other