BEUDAMED
    FDA Adverse Event Other Summary report: N

    TENOR

    MDR report key: 2163480 · Received July 4, 2011

    Report

    Report Number
    3004468271-2011-00029
    Event Type
    Other
    Date Received
    July 4, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 8, 2011
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) BY ARJOHUNTLEIGH (REGISTRATION# 1419652) ON BEHALF OF THE MANUFACTURER MEDIBO MEDICAL PRODUCTS (B)(4) (REGISTRATION# 3004468271). IT IS INDICATED FROM THE ARJOHUNTLEIGH ON-SITE REPORT THAT ALTHOUGH NO PERSON DROPPED OR RECEIVED ANY INJURY, THERE WAS A NEAR-INCIDENT WHERE A SLING WAS USED THAT WAS NOT SUITABLE, CAUSING A PERSON TO ALMOST DROP. DEATH OR SERIOUS INJURIES HAVE OCCURRED BEFORE FROM THIS FAILURE MODE, WHICH IS AN APPARENT USE ERROR: WRONG SIZE OF SLING USED. ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    PT CARE TECH (PCT) WAS TRANSFERRING THE PT FROM A CHAIR TO THE BED WITH A TENOR DEVICE. THE PT STARTED TO FALL OUT OF THE SLING, BUT THE PCT LOWERED THEM TO THE FLOOR TO AVOID ANY INCIDENT. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENOR PASSIVE FLOOR LIFT FSA MEDIBO MEDICAL PRODUCTS NV KHA1010-US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other