BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DECOMPRESSION OF CHOICE

    MDR report key: 19629993 · Received June 27, 2024

    Report

    Report Number
    3007278668-2024-00003
    Event Type
    Malfunction
    Date Received
    June 27, 2024
    Date of Event
    June 13, 2024
    Report Date
    June 27, 2024
    Manufacturer
    PIVOTAL HEALTH SOLUTIONS
    Product Code
    ITH
    UDI-DI
    00850008449826
    PMA / PMN Number
    K101889
    Removal / Correction Number
    94815
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A WELD ON PART E7130 FAILED WHILE THE TABLE WAS IN USE. THERE WAS NO INJURY, HOWEVER THE DOCTOR'S FLOOR WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184997 DECOMPRESSION OF CHOICE DECOMPRESSION TABLE ITH PIVOTAL HEALTH SOLUTIONS E9011 00850008449826

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown