BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRETCHER ASSEMBLY WITH MATTRESS

    MDR report key: 3738537 · Received March 21, 2014

    Report

    Report Number
    2020676-2014-00006
    Event Type
    Injury
    Date Received
    March 21, 2014
    Date of Event
    February 20, 2014
    Report Date
    March 21, 2014
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STRETCHER PLATE HEADREST WAS EVALUATED BY A REPRESENTATIVE (FIELD SERVICE TECHNICIAN) OF THE MANUFACTURER. DURING HIS INVESTIGATION THE REPRESENTATIVE WAS INFORMED THAT THE HYPERBARIC TECHNICIAN HAD RAISED THE HEADREST BY USING THE BLACK KNOBS, WHICH WERE TURNED TO RETRACT THE BRACKET AND THEN RELEASED TO ALLOW FOR ENGAGEMENT OF THE BRACKET INTO ONE OF THE CUT-OUT HOLES. THIS IS NOT THE PROPER USE OF THE STRETCHER HEADREST. THE SILVER BAR IS TO BE PULLED UPWARD TO ENGAGE THE BRACKET AND THE BLACK KNOBS TURNED TO DISENGAGE THE BRACKET. TURNING THE KNOBS TO TRY AND ENGAGE THE BRACKET MAY RESULT IN BRACKET NOT ENGAGING PROPERLY. THE REPRESENTATIVE REBUILT THE HEADREST ASSEMBLY AND VERIFIED PROPER OPERATION OF THE DEVICE. STRETCHER PLATES DO NOT HAVE SERIAL NUMBERS; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. A FOLLOW-UP CALL WAS MADE TO THE HYPERBARIC TECHNICIAN. SHE REPORTED THAT HER THUMB WAS HEALING AND SHE IS ABLE TO USE THE APPENDAGE. THERE IS STILL PAIN, HOWEVER, THE PAIN IS BEARABLE.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED AND STATED THAT THE HEADREST ISN'T FUNCTIONING PROPERLY. THE EVENT OCCURRED DURING CLINICAL USE. THERE WAS NO INJURY TO THE PATIENT. WHEN THE MANUFACTURER'S REPRESENTATIVE WAS ON SITE TO EVALUATE AND REPAIR THE STRETCHER PLATE THE MANUFACTURER BECAME AWARE THAT THERE WAS AN INJURY TO THE HYPERBARIC TECHNICIAN. THE HEADREST OF THE STRETCHER PLATE WAS IN THE UPRIGHT POSITION. THE HYPERBARIC TECHNICIAN GRABBED THE SILVER BAR WITH HER RIGHT HAND TO PULL THE STRETCHER PLATE OUT OF THE CHAMBER. HER LEFT HAND WAS UNLOCKING THE STRETCHER PLATE FROM THE CHAMBER USING THE SILVER UNLATCH KNOB. AS SHE STARTED PULLING THE STRETCHER PLATE OUT OF THE HYPERBARIC CHAMBER THE STRETCHER HEADREST CAME DOWN. THE HYPERBARIC TECHNICIAN'S RIGHT HAND WAS STILL HOLDING THE METAL BAR AND HER THUMB HIT THE STRETCHER PLATE AND BOUNCED BACK. THE HYPERBARIC TECHNICIAN WAS TAKEN TO EMPLOYEE HEALTH BY HER MANAGER. HER HAND WAS ICED AND SHE WAS GIVEN NAPROXEN FROM THE CONTUSION. PER THE HYPERBARIC TECHNICIAN, HER HAND WAS BLACK, BLUE AND SWOLLEN. IT HURT TO TRY AND TURN A KNOB. AN MRI WAS CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170625 STRETCHER ASSEMBLY WITH MATTRESS STRETCHER PLATE BTT SECHRIST INDUSTRIES, INC. 21363

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention