BEUDAMED
    FDA Adverse Event Other Summary report: N

    TEMPO

    MDR report key: 2438131 · Received February 1, 2012

    Report

    Report Number
    9681684-2012-00008
    Event Type
    Other
    Date Received
    February 1, 2012
    Date of Event
    December 29, 2011
    Report Date
    January 3, 2012
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH ON BEHALF OF THE MANUFACTURER ARJOHUNTLEIGH (B)(4). PLEASE NOTE THAT WHILE THIS PRODUCT IS NO LONGER MANUFACTURED, PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO (B)(4). AS OF (B)(4) 2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY (B)(4). THE EVALUATION OF THE DEVICE TO DATE HAS BEEN CARRIED OUT BY A REPRESENTATIVE OF THE MANUFACTURER'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    WHILE THE RESIDENT WAS BEING MOVED WITH A TEMPO FLOOR LIFT AND A CLIP SLING FOR A TRANSFER FROM BED TO WHEELCHAIR, THE RIGHT SHOULDER CLIP CAME LOOSE AND RESIDENT SLID OUT OF THE SLING ONTO FLOOR. RESIDENT WAS TAKEN TO EMERGENCY ROOM AND RELEASED SHORTLY THEREAFTER WITH NO INJURIES REPORTED AT THAT TIME. TWO DAYS LATER, HE WAS HOSPITALIZED FOR A POSSIBLE HEAD INJURY, BUT IT IS UNDETERMINED IF THE INJURY IS RELATED TO THE FALL OR NOT. NO DETAILS WERE PROVIDED ABOUT THE TREATMENT GIVEN AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPO MANUFACTURED FLOOR PASSIVE LIFT FSA ARJO MED AB LTD KPA5010

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| O