BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RATCHET TOWER

    MDR report key: 16507775 · Received March 8, 2023

    Report

    Report Number
    2921578-2023-00002
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 27, 2023
    Report Date
    May 24, 2023
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    UDI-DI
    00842430104220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE RETURNED TO THE MANUFACTURER WAS RECEIVED IN A DISASSEMBLED FASHION. THIS MADE IT UNABLE TO CONDUCT PROPER DEVICE EVALUATION TO IDENTIFY THE ROOT CAUSE OF THE INCIDENT. AN IN-SERVICE TRAINING IS REQUESTED TO EDUCATE THE CUSTOMER ON PREVENTATIVE MAINTENANCE AND REPAIR PROCEDURES.

    Description of Event or Problem · 0

    TABLE LOWERED ON ITS OWN DURING SURGERY.

    Description of Event or Problem · 0

    TABLE LOWERED ON ITS OWN DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716686 RATCHET TOWER MOUNTING BRACKET JEA MIZUHO OSI 7803-579 00842430104220

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown