BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-SPECIALTY POSITIONING KT, W/ARM PADS & LIFT SHEET

    MDR report key: 21424550 · Received February 20, 2025

    Report

    Report Number
    1043214-2025-00001
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    February 5, 2025
    Report Date
    March 20, 2025
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    CCX
    UDI-DI
    00749756390248
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEROYAL INDUSTRIES REQUESTED RETURN OF THE DEVICE, BUT IT WAS NOT AVAILABLE. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SENT TO THE SUPPLIER. HOWEVER, IT WAS DETERMINED THAT THIS WAS NOT A SUPPLIER ISSUE AND THE SCAR WAS RESCINDED. THE COMPLAINT REPORTED A SLIDE AND ASKED IF THERE WAS A WEIGHT LIMIT WITH THE DEVICE. THE IFU AND PAMPHLET FROM THE DEROYAL WEBSITE STATES THAT THIS PRODUCT SHOULD NOT BE USED ON PATIENTS OVER 500 POUNDS. THERE IS NO LOWER WEIGHT LIMIT. FURTHER INFORMATION WAS GATHERED FROM THE SALES MANAGER OF THE REPORTING CUSTOMER. IT WAS FOUND THAT PATIENT MOVED ABOUT 8-12 INCHES ON THE PAD. THE CUSTOMER ALSO STATED THAT THEY DID HAVE TO MOVE THE PATIENT AROUND A GOOD BIT AT THE BEGINNING OF THE PROCEDURE AND STATED THAT THEY THOUGHT THAT MIGHT HAVE BEEN WHEN SHE HAD MOVED. THE CUSTOMER ALSO CONFIRMED THAT AFTER THEY RESET HER POSITION SHE STAYED THERE THE REST OF THE PROCEDURE WITH NO FURTHER MOVEMENT ISSUES. BECAUSE NO LOT NUMBER WAS PROVIDED, NO WORK ORDER COULD BE REVIEWED FOR THE MANUFACTURING PROCESS. DEROYAL DID REVIEW LABELING AND THE FAILURE MODES AND EFFECTS ANALYSIS FOR THE PRODUCT AND NO ISSUES WERE FOUND. NO INVENTORY WAS ON HAND AT DEROYAL TO BE INSPECTED. A COMPLAINT TO SALES RATIO WAS CONDUCTED OVER THE PAST TWO YEARS AND FOUND TO BE 0.22%. ROOT CAUSE: BECAUSE THE SAMPLE WAS NOT ABLE TO BE RETURNED AND NO LOT NUMBER WAS PROVIDED, THE INVESTIGATION ABLE TO BE PERFORMED WAS LIMITED. WITH THE LIMITED INFORMATION AND NO ISSUES FOUND WITH THE INVESTIGATION ABLE TO BE PERFORMED, NO ROOT CAUSE WAS ABLE TO BE DETERMINED. POTENTIAL ROOT CAUSE: BASED ON ADDITIONAL CONVERSATIONS WITH THE CUSTOMER AND THE SALES MANAGER, THERE IS A POTENTIAL THAT THIS ISSUE COULD HAVE BEEN A USER ERROR. HOWEVER, WITHOUT MORE INFORMATION, THIS COULD NOT BE CONFIRMED. CORRECTIVE AND PREVENTIVE ACTIONS: BECAUSE NO ROOT CAUSE WAS ABLE TO BE DETERMINED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "WE HAD A PATIENT THAT SLID ON THE BED TODAY USING THE BLACK PAD. HER LEGS WERE STRAIGHT, AND SHE WAS A VERY TINY GIRL. IS THERE A WEIGHT LIMIT AS TO MAYBE SHE WAS TOO SMALL AND THAT'S WHY SHE SLID." DEROYAL INDUSTRIES REQUESTED RETURN OF THE DEVICE, BUT IT WAS NOT AVAILABLE. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SENT TO THE SUPPLIER. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED, "WE HAD A PATIENT THAT SLID ON THE BED TODAY USING THE BLACK PAD. HER LEGS WERE STRAIGHT, AND SHE WAS A VERY TINY GIRL. IS THERE A WEIGHT LIMIT AS TO MAYBE SHE WAS TOO SMALL AND THAT'S WHY SHE SLID"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465663 MULTI-SPECIALTY POSITIONING KT, W/ARM PADS & LIFT SHEET SUPPORT, PATIENT POSITION CCX DEROYAL INDUSTRIES, INC. M60-SF505 00749756390248

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown