BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRYKER OEM GURNEY

    MDR report key: 2724959 · Received August 29, 2012

    Report

    Report Number
    2020676-2012-00038
    Event Type
    Other
    Date Received
    August 29, 2012
    Date of Event
    July 27, 2012
    Report Date
    August 29, 2012
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A TECH FROM THE OEM MANUFACTURER EVALUATED THE GURNEY ON (B)(4) 2012. HE INSPECTED THE GURNEY LOCKING MECHANISM, WHICH IS LOCATED ON THE GURNEY (LOCKS THE STRETCHER PLATE TO THE GURNEY), AND FOUND IT TO BE IN OPERATIONAL CONDITION. THE STRETCHER LEVER AND SPRING LOCKING MECHANISM (FITS INSIDE THE GURNEY LOCKING MECHANISM) WAS EVALUATED AND FOUND TO BE IN OPERATIONAL CONDITION. THERE WAS NO BINDING WITH THE LEVER AND/OR SPRING AND NO ISSUES WITH THE LOCKING BOLT. NEXT, THE GURNEY WAS PLACED IN THE SAME POSITION, AS WAS REPORTED PER THE INCIDENT. THE HEAD END WAS PLACED AS HIGH AS IT COULD GO WITH THE FOOT END OF THE GURNEY PLACED TO ITS LOWEST LEVEL, TRENDELENBURG POSITION. THE STRETCHER WAS LOCKED INTO PLACE ON THE GURNEY. THE TECH GOT ON THE STRETCHER PLATE AND TRIED TO GET THE PLATE TO DISENGAGE. HE MOVED AROUND ON THE PLATE VIGOROUSLY AND WAS UNABLE TO DISCONNECT THE PLATE FROM THE GURNEY. SEVERAL ATTEMPTS WITH VARYING CONDITIONS WERE ATTEMPTED. THE LOCKING MECHANISM WOULD NOT FAIL AND THE REPORTED INCIDENT COULD NOT BE DUPLICATED. A FOLLOW-UP CALL WAS PLACED TO THE CENTER ON 08/29/2012, FOR A STATUS UPDATE ON THE PT. THE PT COMPLETED TREATMENTS APPROXIMATELY 2 WEEKS AFTER THE INCIDENT. HE CONTINUED TO COMPLAIN ABOUT BACK PAIN. THE PROGRAM DIRECTOR OF THE CENTER REPORTED THAT SEVERAL RECOMMENDATIONS WERE MADE TO THE PT TO SEE HIS REGULAR DOCTOR OR TO SEE AN ORTHOPEDIST. DURING THOSE TWO WEEKS, IT WAS REPORTED THAT THE PT DID NOT SEEK OUTSIDE MEDICAL TREATMENT. PT INFO: MALE. BORN IN 1942 (APPROXIMATELY (B)(6)). DIAGNOSIS: LATE EFFECTS OF RADIATION.

    Description of Event or Problem · 1

    THE OEM MANUFACTURER RECEIVED A REPORT THAT ON (B)(6) 2012, THERE WAS A PT INVOLVED INCIDENT WITH A HYDRAULIC GURNEY USED FOR HYPERBARIC TREATMENTS. THE FOLLOWING IS THE INCIDENT AS IT WAS REPORTED TO THE OEM MANUFACTURER: THE GURNEY WAS RAISED ABOVE THE DEFAULT HEIGHT (CHAMBER RAIL HEIGHT). THE HYPERBARIC TECH PUSHED ROD IN FROM HEAD OF GURNEY TO LOWER PT, STEPPED AROUND TO LOWER SIDE RAIL OF GURNEY, AND THE FOOT END OF GURNEY LOWERED BELOW HEAD END. THE PT HAD STARTED TO SIT UP, AS THE STRETCHER TILTED DOWNWARD AT THE FOOT END WHEN THE STRETCHER DISENGAGED FROM THE LOCKING MECHANISM ON THE GURNEY AND THE FOOT END HIT THE GROUND. THE TILT WAS A SLOW DECENT, THE PT DID NOT FALL OFF OR HIT THE GROUND. HE SLID INTO THE BAG OF LINEN THAT WAS ON THE FLOOR NEXT TO WHERE THE STRETCHER PLATE TOUCHED THE GROUND. THE PT HAD NOT PUT HIS LEGS OVER THE SIDE OF THE STRETCHER PLATE PRIOR TO THE EVENT OCCURRING. HIS HIPS AND KNEES WERE BENT WHEN HE SLID INTO THE LINEN BAG. THE PT WAS COMPLAINING ABOUT BACK PAIN, SO THE DOCTOR SENT HIM TO THE EMERGENCY ROOM TO BE EXAMINED. ON MONDAY, (B)(6) 2012, THE PT RETURNED FOR HYPERBARIC TREATMENT. HE WAS STILL COMPLAINING OF PAIN. THE EMERGENCY ROOM DOCTOR HAD PUT HIM ON PAIN MEDICATION AND HE WAS INFORMED HE SHOULD SEE AN ORTHOPEDIST OR HIS FAMILY DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER OEM GURNEY HYDRAULIC GURNEY FPO SECHRIST INDUSTRIES, INC. 21465-00

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR