BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIRANTI

    MDR report key: 1952235 · Received October 12, 2010

    Report

    Report Number
    9611530-2010-00074
    Event Type
    Other
    Date Received
    October 12, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MFG BY ARJO (B)(4) WILL BE REPORTED BY US, THE LEGAL MFR, ARJO (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN (B)(4), ARJO (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 (B)(6) 2010: "CALL CAME IN WHERE A PT WAS BEING BATHED IN A MIRANTI. AS THEY WERE BEING DRIED OFF, THEY ROLLED OFF THE FRONT OF THE DEVICE. THE STAFF MEMBERS CAUGHT THE RESIDENT BEFORE THEY FELL TO THE FLOOR. THE FACILITY REP CLAIMED THAT THE BAR WASN'T DOWN WHEN THEY WERE DRYING THE PT OFF; HE ALSO LOOKED AT THE UNIT AND DID NOT FIND ANYTHING WRONG INITIALLY, SO THE UNIT WAS PUT BACK INTO SERVICE." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRANTI LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB CEB8303-01

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR