BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNRISE MEDICAL INC-SLING

    MDR report key: 151950 · Received January 22, 1998

    Report

    Report Number
    151950
    Event Type
    Injury
    Date Received
    January 22, 1998
    Date of Event
    December 8, 1997
    Report Date
    December 16, 1997
    Manufacturer
    SUNRISE MEDICAL, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    12/8/97 AN EMPLOYEE WAS IN THE SLING, WHEN IT RIPPED ALONG STITCHING LINE. AN EMPLOYEE, MFR'S REP, AND DISTRIBUTOR'S REP WERE ALL PRESENT. THEY WERE DEMONSTRATING USE OF PT LIFT IN THE HOME WHEN SLING RIPPED AND THE EMPLOYEE FELL TO FLOOR INJURING HER RT ELBOW AND RT SHOULDER. POSSIBLE LONG TERM NERVE DAMAGE. FIRST TIME SLING WAS USED. STITCHING ON SIDE THAT RIPPED HAD RT SIDE. ONE ROW OF STITCHING AND LT HAD 5 ROWS OF STITCHING. WHAT HAPPENED: AT APPROX 3:15 P.M. TODAY, A DISTRIBUTOR REP AND A SUNRISE MEDICAL REP WERE DEMONSTRATING THE USE OF A "PARTNER PT LIFT". THE REPS WERE AT THE HOME OF A CUSTOMER WHO WAS ALSO PRESENT DURING THE DEMONSTRATION. THE REPS WERE THERE TO DEMONSTRATE THIS LIFT TO THE CUSTOMER AND THE STAFF FROM HOME CARE AGENCY. THE MFR REP STARTED THE DEMONSTRATION WITH AN ORAL OVERVIEW OF THE PT LIFT AND SLING. THE REPS THEN DEMONSTRATED THE LIFT USING AN EMPLOYEE AS A "PT". AFTER A SUCCESSFUL LIFTING DEMONSTRATION, THE REPS SWITCHED CAREGIVERS AND HAD ANOTHER EMPLOYEE BECOME THE "PT". THE REPS THEN PROCEEDED TO LIFT THE EMPLOYEE. AFTER SUCCESSFUL LIFTING, THE REPS DEMONSTRATED THE "TRANSPORT" POSITION FOR RELOCATION OF THE PT. AT THIS TIME, THE SHOULDER STRAP ON THE RIGHT SIDE SNAPPED AND THE EMPLOYEE FELL. SHE FELL ONLY A MATTER OF INCHES SINCE THE REPS HAD HER IN A "TRANSPORT" HEIGHT. HOWEVER, SHE LANDED ON HER ELBOW WHICH HAD BEEN PREVIOUSLY INJURIED IN ANOTHER ACCIDENT. THE EMPLOYEE OBVIOUSLY WAS IN A LOT OF PAIN AND DISCOMFORT. SHE DESCRIBED TO THE REPS THE PREVIOUS INJURY TO HER ELBOW AND HOW SHE HAD NERVE PROBLEMS IN THAT ELBOW. THE EMPLOYEE WAS TRANSPORTED (BY HOME CARE STAFF) TO THE HOSP FOR TREATMENT. THE MFR REP LOOKED AT THE STRAP TO DETERMINE WHAT MAY HAVE GONE WRONG. HE NOTICED AND CALLED TO THE DISTRIBUTOR REP'S ATTENTION THAT THE STRAP ON THE LEFT SIDE HAD 5 ROWS OF STITCHING ACROSS IT AND THEN SHOWED THE DISTRIBUTOR REP THE STRAP ON THE RIGHT SIDE HAD ONLY ON ROW OF STITCHING. IT WAS APPARENT THAT THIS FAILURE WAS CAUSED BY A DEFECTIVE SEWING PROCESS ON THIS SLING. THE MFR REP TOOK THE SLING WITH HIM TO SEND TO SUNRISE FOR THEIR QUALITY CONTROL PEOPLE TO LOOK AT. THE MFR REP TOLD THE EMPLOYEE THAT HE WAS SORRY FOR THE INCIDENT AND THAT SUNRISE WOULD TAKE CARE OF HER MEDICAL EXPENSES. NOTE: THIS WAS A NEW LIFT AND SLING (OUT OF THE BOX). THE DISTRIBUTOR REP HAD OPENED AND REMOVED THE SLING FROM THE PLASTIC SHIPPING PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUNRISE MEDICAL INC-SLING PATIENT LIFT DEVICE FSA SUNRISE MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention MRI, PHYSICIAN'S VISITS, ER, PHYSICAL THERAPY,| CURRENTLY NOT WORKING.