BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRI FOWLER BACK STRETCHER

    MDR report key: 8185257 · Received December 20, 2018

    Report

    Report Number
    2431314-2015-00001
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    November 5, 2015
    Report Date
    November 6, 2015
    Manufacturer
    BIODEX MEDICAL SYSTEMS, INC.
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    BIODEX RECEIVED THE MEDWATCH REPORT FROM THE FDA. WE DID NOT RECEIVE ANYTHING FROM THE MEDICAL CENTER. BIODEX RECEIVED THE REPORT FROM THE FDA ON NOVEMBER 16TH, 2015. WE TRIED CONTACTING (B)(6) AND LEFT A PHONE MESSAGE. ON NOVEMBER 20TH, I SPOKE TO (B)(6) AND SHE TOLD ME TO TALK TO (B)(6), BIOMEDICAL ENGINEERING. IN NOVEMBER, WE SPOKE TO (B)(6). THEY SAID A CASTER CAME LOOSE AND CAME OFF THE STRETCHER. THE STRETCHER FLIPPED WITH THE PATIENT ON THE STRETCHER. (B)(6) TOLD US THAT THE OTHER CASTERS WERE LOOSE. HE ORDERED A NEW CASTER AND INSTALLED IT ONTO THE STRETCHER. AT THE SAME TIME, HE TIGHTENED THE OTHER CASTERS. HE TOLD US HE THEN CHECKED THE OTHER MRI STRETCHER AND THOSE CASTERS WERE TIGHT. HE DID NOT KNOW IF THEY HAD USED THE RESTRAINING STRAPS OR HAD THE SIDE RAILS UP ON THE STRETCHER. HE TOLD US THESE WOULD HAVE HELPED THE PATIENT. (B)(6) TOLD US THEY NEVER PERFORMED ANY PERIODIC MAINTENANCE OR CHECKED THE STRETCHERS IN THE YEARS THEY HAD THEM. THEY WILL PERIODICALLY CHECK THE CASTERS IN THE FUTURE. THE INSTRUCTION MANUAL SAYS TO PERIODICAL CHECK THAT THE CASTERS HAVE NOT LOOSENED. TIGHTEN IF REQUIRED.

    Description of Event or Problem · 1

    WHEN PATIENT WAS PLACED ON THE MRI STRETCHER, THE WHEEL FELL OFF AND THE PATIENT FELL TO THE FLOOR FACE DOWN. HE WAS TAKEN TO THE ED FOR EVALUATION AND IMAGING STUDIES WERE COMPLETED, WHICH WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027632 MRI FOWLER BACK STRETCHER MRI STRETCHER FPO BIODEX MEDICAL SYSTEMS, INC. 240-110

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention