BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOYER LIFT W/6PTWSC

    MDR report key: 1784991 · Received March 10, 2010

    Report

    Report Number
    2182305-2010-00003
    Event Type
    Other
    Date Received
    March 10, 2010
    Date of Event
    January 24, 2010
    Report Date
    February 19, 2010
    Manufacturer
    IMS, INC, INTEGRATED MEASUREMENT SYSTEM
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BECAUSE OF A FINISHED DEVICE COMPONENT SUPPLIER'S PART THAT FAILED WHILE IN USE ON OUR MEDICAL DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MFR, BY DEALER SUNRISE MEDICAL (B)(4), PER THEIR CUSTOMER THEIR PT WAS IN BED AND THEY WERE STARTING TO RAISE HIM, WHEN THE PIN THAT HOLDS THE SCALE AND CRADLE TO THE MAST HAD BROKEN. PT FELL BACK ONTO HIS BED. AND THE CRADLE AND SCALE FELL ON THE HEAD OF THE PT. HE WAS TAKEN TO THE HOSPITAL AND RELEASED THE SAME DAY. INCIDENT REPORT FROM THE HOSPITAL STATES PT WAS NOT HURT, NO INJURY AND NO PAIN AT THE MOMENT OF THE INCIDENT, BUT ONE HOUR LATER THERE WAS A PRESENCE OF EDEMA ON THE UPPER LIP. (B)(4) WAS ISSUED TO GET LIFT COMPONENT PARTS BACK FOR EVAL. IN ADDITION THE MFR OF THE SCALE HAS BEEN NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER LIFT W/6PTWSC PATIENT LIFTER W/SCALE FNG IMS, INC, INTEGRATED MEASUREMENT SYSTEM PRESENCE W/6POINT SCALE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other