BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DECOMPRESSION OF CHOICE

    MDR report key: 19336621 · Received May 16, 2024

    Report

    Report Number
    3007278668-2024-00001
    Event Type
    Malfunction
    Date Received
    May 16, 2024
    Date of Event
    April 26, 2024
    Report Date
    May 15, 2024
    Manufacturer
    PIVOTAL HEALTH SOLUTIONS
    Product Code
    ITH
    UDI-DI
    00850008449826
    PMA / PMN Number
    K101889
    Removal / Correction Number
    3007278668-5/17/24-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS UNCRATING THE PRODUCT AND MOVING THE DEVICE WHEN THE LUMBAR END OF THE TABLE WAS IDENTIFIED AS BEING LOOSE. WHEN THE DEVICE CONTINUED TO BE MOVED THE DOCTOR DETERMINED THAT THE LUMBAR ADJUSTMENT SECTION OF THE DEVICE WAS HANGING LOW INSTEAD OF HORIZONTAL AND AT THAT TIME THE CUSTOMER COULD SEE BETWEEN THE LUMBAR AND THORACIC CUSHIONS THAT A WELD HAD BEEN COMPROMISED ON THE FRAME. THE CUSTOMER CONTACTED PIVOTAL HEALTH SOLUTIONS AND SENT A PICTURE AND PIVOTAL HEALTH SOLUTIONS WAS ABLE TO VERIFY THAT A WELD HAD FAILED AND THEN TOOK IMMEDIATE ACTION TO HAVE THE TABLE RETURNED TO THE MANUFACTURER. THERE WAS NO PATIENT USE ON THIS DEVICE.

    Description of Event or Problem · 0

    THE WELD ON THE LUMBAR SECTION OF THE TABLE FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670217 DECOMPRESSION OF CHOICE DECOMPRESSION TABLE ITH PIVOTAL HEALTH SOLUTIONS E9011 00850008449826

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown