BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DECOMPRESSION OF CHOICE

    MDR report key: 19342108 · Received May 17, 2024

    Report

    Report Number
    3007278668-2024-00002
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Date of Event
    April 29, 2024
    Report Date
    May 16, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED THE MANUFACTURER TO REPORT THAT AS THEY WERE UNCRATING THE TABLE AND WERE IN THE PRCOESS OF MOVING THE TABLE, THE LUMBAR SECTION OF THE TABLE WAS OBSERVED AS NOT BEING HORIZONTAL AND LEVEL WITH THE OTHER CUSHION SECTIONS, IT WAS TIPPED DOWNARD. PICTURES WERE SENT BY THE CUSTOMER TO THE MANUFACTURER AND IT WAS DETERMINED THAT THERE MAY BE A PARTIAL WELD BREAK AND THE IMMEDIATE DECISION WAS MADE TO HAVE THE TABLE SHIPPED BACK TO THE MANUFACTURER. THERE WAS NO PATIENT CONTACT WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531006 DECOMPRESSION OF CHOICE DECOMPRESSION TABLE ITH PIVOTAL HEALTH SOLUTIONS E9011 00850008449826

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown