BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRETCHER PLATE

    MDR report key: 7785700 · Received August 15, 2018

    Report

    Report Number
    2020676-2018-00013
    Event Type
    Injury
    Date Received
    August 15, 2018
    Date of Event
    March 30, 2018
    Report Date
    July 20, 2018
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    FPO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    S.I. FIELD SERVICE TECHNICIAN INSPECTED THE STRETCHER PLATE AND ROLLERS AND FOUND THEY WERE IN GOOD WORKING CONDITION. THERE WERE NO SIGNS OF DAMAGE OR EXCESSIVE WEAR ON EITHER THE STRETCHER PLATE NOR THE ROLLERS. THERE WAS ONE ROLLER WITH MINIMAL NOISE BUT THIS HAD NO IMPACT ON MOVING THE STRETCHER PLATE IN AND OUT OF THE CHAMBER. S.I. FIELD SERVICE TECHNICIAN SPOKE WITH THE BIOMED PERSON WHO INDICATED THAT THEY HAVE CHANGED THEIR PROCEDURE ON PUSHING AND PULLING THE STRETCHERS INTO THE CHAMBERS WHEN THERE IS A PATIENT OF SUBSTANTIAL SIZE, THEY ARE TO HAVE TWO PERSONS PERFORMING THIS TASK TO PREVENT THIS FROM REOCCURRING.

    Description of Event or Problem · 1

    INITIAL REPORT RECEIVED FROM THE CUSTOMER WAS THAT THEY HAD AN HBO TECHNICIAN WHO RECEIVED A TORN LIGAMENT IN HIS LEFT SHOULDER WHICH WAS CAUSED BY REPEATED USE OF PULLING IN/OUT AN OBESE PATIENT WEIGHING APPROXIMATELY (B)(6). STAFF FEELS IT WAS CAUSED BY THE WHEELS ON THE STRETCHER PLATE BEING DIFFICULT TO MOVE IN AND OUT OF THE CHAMBER DUE TO WORN CASTERS. ON 8/13/2018 MORE INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THE INJURY OCCURRED ON (B)(6) 2018 AND THE HBO TECHNICIAN HAD SURGERY TO REPAIR THE TORN LIGAMENT ON HIS LEFT SHOULDER ON (B)(6) 2018. THE HBO TECHNICIAN IS ON MEDICAL LEAVE AND IS RECOVERING. THE HOSPITAL HAS CHANGED THEIR PROCEDURE FOR PULLING AND PUSHING A STRETCHER INTO AND OUT OF THE CHAMBER WITH A PATIENT AT (B)(6) OR GREATER THAT THERE MUST BE TWO PERSONS PERFORMING THIS FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628170 STRETCHER PLATE STRETCHER PLATE FPO SECHRIST INDUSTRIES, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention