BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANDAGO

    MDR report key: 7143901 · Received December 22, 2017

    Report

    Report Number
    3003781275-2017-00002
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    November 7, 2017
    Report Date
    December 22, 2017
    Manufacturer
    HOCOMA AG
    Product Code
    BXB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE CUSTOMER IN USA REPORTED A BROKEN HANDRAIL ON THE ANDAGO V2.0. (HANDRAILS ARE OPTIONAL COMPONENTS). IT OCCURED WHILE SERVICING THE MEDICAL DEVICE, NOT WHILE A THERAPY. NO PATIENT TRAINING ONGOING SO NOBODY (PATIENT, USER AND 3RD PERSONS) WERE INJURED. HOWEVER THE POTENTIAL HARM, COULD OCCUR DURING PATIENT SETUP AND RELEASE, WHICH COULD LEAD TO A SERIOUS INJURY. (SAFETY RELATED). AS THIS CASE IS RELATED TO PATIENT SAFETY, HOCOMA DECIDED TO INITIATE A MDR IN THE US. WE HAVE IDENTIFIED 19 (NINETEEN) ANDAGO V2.0 PRODUCTS IN USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920657 ANDAGO POWERED EXCERCISER BXB HOCOMA AG

    Patients

    Seq Age Sex Outcome Treatment
    1