BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DANTEC KEYPOINT G4

    MDR report key: 8179574 · Received December 19, 2018

    Report

    Report Number
    3004827015-2018-00003
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    December 11, 2018
    Report Date
    February 13, 2019
    Manufacturer
    ALPINE BIOMED APS
    Product Code
    GWF
    PMA / PMN Number
    K944547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER HAS NOTED THAT THEY MIGHT SEND BACK FAULTY PART. WAITING RETURN OF DEVICE FOR EVALUATION. WORK ORDER REQUESTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: THE COMPLAINT LOG WAS REVIEWED FOR THIS PART NUMBER AND LOT NUMBER, 1 SIMILAR COMPLAINTS RECEIVED OVER THE LAST 12 MONTHS FOR THIS PART AND LOT. NO TREND HAS BEEN OBSERVED. ADDITIONAL INFORMATION: THE SERIAL NUMBER WAS OBTAINED BY THE ORIGINATOR, QA REACHED OUT TO INCOMING INSPECTION TO GET A MANUFACTURER DATE AND ANY EXTRA INFORMATION HOWEVER THIS DATA IS NOT RECORDED AT INCOMING INSPECTION. THIS PART WAS SUPPLIED BY A FORMER SUPPLIER AND WAS MANUFACTURED CIRCA 2008 BY KURT HANSEN PROJEKT A/S. NATUS NO LONGER ARE AFFILIATED WITH THIS SUPPLIER AND AS THIS DEVICE IS OVER 10 YEARS OLD IT HAS REACHED END OF SERVICE AND THE PART CANNOT BE INVESTIGATED BY THE SUPPLIER. THERE IS NO FURTHER INFORMATION TO COMPLETE THE INVESTIGATION AND THEREFORE THE CASE HAS BEEN CLOSED. REPLACEMENT PART HAS BEEN SENT TO THE CUSTOMER IN ORDER TO RECTIFY THE ISSUE BY OUR CURRENT SUPPLIER. NO FURTHER ACTIONS CARRIED OUT, THIS ISSUE WILL BE CONTINUED TO BE MONITORED IN THE FUTURE FOR ANY TRENDS RELATING TO THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THE RISK OF THIS COMPLAINT WAS REVIEWED UNDER (B)(4). HAZARD AND HARM ASSOCIATED WITH PHYSICAL INJURY WAS IDENTIFIED. HAZARD ID 6.6: FAULT IN CART ARM CAUSES IT TO FALL UNEXPECTEDLY WHILE EQUIPMENT IS ATTACHED TO PATIENT. EFFECTS (HARM): PATIENT OR OPERATOR INJURED. THE RESIDUAL RISK FOUND WAS 3. THE RESIDUAL RISK WAS FOUND TO BE ACCEPTABLE BASED OF THE RISK BENEFIT RATIONALE. THE COMPLAINT LOG WAS REVIEWED FOR THIS PART NUMBER AND LOT NUMBER, NO SIMILAR COMPLAINTS RECEIVED OVER THE LAST 12 MONTHS FOR THIS PART AND LOT. NO TREND HAS BEEN OBSERVED. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: PATIENT INFORMATION - NO PATIENT INJURY INITIALLY REPORTED, DEVICE MALFUNCTION OCCURRED. THE MEDICAL DEVICE DOES NOT HAVE A LOT NUMBER. THE MEDICAL DEVICE IS NOT IMPLANTABLE. MANUFACTURE DATE - INFORMATION NOT AVAILABLE AT THE TIME OF THE REPORT THIS WILL BE SUBMITTED IN THE FOLLOW UP REPORT.

    Description of Event or Problem · 1

    DEFECTIVE AMPLIFIER ARM, PART NUMBER: 9031B0511. ISSUE WITH A SCREW UNDER THE AMPLIFIER ARM - DOESN'T HOLD WHEN TURNING THE ARM - PARTS FALL ON USERS. THIS INCIDENT OCCURRED DURING AN EXAM. NO INJURY OCCURRED AS THE ARM WAS STILL ATTACHED BY THE CABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020973 DANTEC KEYPOINT G4 AMPLIFIER ARM, DUAL GWF ALPINE BIOMED APS 9031B0511

    Patients

    Seq Age Sex Outcome Treatment
    1 Other