BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO GRAVITY

    MDR report key: 11713424 · Received April 23, 2021

    Report

    Report Number
    2182318-2021-00001
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 19, 2021
    Report Date
    March 23, 2021
    Product Code
    EAJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE MULTIPLE ATTEMPTS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. IT WAS REPORTED THAT THE CABLE BETWEEN THE BALANCER AND THE BODY SHIELD BROKE DURING AN OPERATION THE BODY SHIELD WAS REPORTED TO BE DAMAGED AS A RESULT OF THIS EVENT. THIS EVENT WAS INITALLY REPORTED THE GERMAN DISTRIBUTOR BIOTRONIK SE & CO. KG BY A PHYSICIAN IN GERMANY. IT WAS CONFIRMED THERE WERE NO RESULTING INJURIES TO THE PATIENT OR CAREGIVER AS A RESULT OF THIS EVENT. PER THE INSTRUCTIONS FOR USE (IFU) EXCESSIVE ROTATION OF THE BODY SHIELD MAY CAUSE THE BALANCER CABLE TO BREAK. THE BODY SHIELD MUST BE LOWERED AND ALLOWED TO UNWIND AFTER EACH USE, IN AN UNLOCKED POSITION. ANNUAL INSPECTIONS MUST BE PERFORMED ON THE CABLE. CABLES MUST BE REPLACED IF THERE ARE ANY SIGNS OF WEAR AND / OR ABNORMALITES. THE REPORTING HOSPITAL FACILITY WAS UNABLE TO SUPPLY ANY MAINTENANCE RECORDS TO SUPPORT THE OCCURRENCE OF REGULAR INSPECTIONS. HISTORICAL COMPLAINTS WERE REVIEWED, AND THERE IS NO REPORTED HARM RELATED TO THIS MALFUNCTION.

    Description of Event or Problem · 1

    THE CABLE BETWEEN THE BALANCER AND BODY SHIELD BROKE DURING AN OPERATION. NO INJURIES WERE SUSTAINED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617242 ZERO GRAVITY ZERO GRAVITY FLOOR SYSTEM EAJ ZGM-6-5H

    Patients

    Seq Age Sex Outcome Treatment
    1