BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLET PC TREX HD MONITORING - REPAIRED

    MDR report key: 17571147 · Received August 18, 2023

    Report

    Report Number
    9612330-2023-00029
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Date of Event
    July 24, 2023
    Report Date
    September 13, 2023
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). THERE ARE NO CAPA'S RELATED TO THIS ISSUE. THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED. PER DOC-010378 HAZARD ID 6.3, SEVERITY 11-NEGLIGIBLE RISK LEVEL MEDIUM. A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. PER QMS-004442, COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. DEVICE HISTORY RECORD WAS REVIEWED, AND NO RELATED FAULTS/ISSUE FOUND. UDI NUMBER: NOT APPLICABLE. INSTALL DATE: 11 NOVEMBER 2019. (B)(6) 2023: ALLEGEDLY DEFECTIVE TABLET WAS RETURNED FOR EVALUATION. AWAITING INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). THE DEFECTIVE PART WAS RETURNED. ENGINEERING LOOKED AT THE ALLEGEDLY DEFECTIVE TABLET AND NOTED THE FOLLOWING: TABLET IS NOT POWERING UP. ROOT CAUSE WAS DETERMINED TO BE "TABLETS DON'T HAVE ANY PHYSICAL DAMAGE, IT LOOKS LIKE BAD BATCH OF TABLES FROM SUPPLIER / MANUFACTURER. " ENGINEERING RECOMMENDED THE TABLETS BE RETURNED TO THE SUPPLIER. RECOMMENDED ACTIONS: RETURN TO SUPPLIER IF TABLETS ARE UNDER WARRANTY. CLOSURE RATIONALE: COMPLAINT VERIFIED, BEING TRACKED AS A TREND. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW.

    Description of Event or Problem · 0

    PART 019761R TABLET PC TREX HD MONITORING - REPAIRED. THE CUSTOMER STATES THAT THE 'TABLET IS HEATING UP TO A DANGEROUS LEVEL'. CUSTOMER MENTIONED MULTIPLE TABLETS 4 IN TOTAL. THE TABLETS THEY HAVE ARE HEATING UP AND KEEP ON RESTARTING, CAUSING THE LOST OF DATA. EVENT 4/4. NO INJURIES.

    Description of Event or Problem · 0

    PART 019761R TABLET PC TREX HD MONITORING - REPAIRED. THE CUSTOMER STATES THAT THE 'TABLET IS HEATING UP TO A DANGEROUS LEVEL'. CUSTOMER MENTIONED MULTIPLE TABLETS 4 IN TOTAL. THE TABLETS THEY HAVE ARE HEATING UP AND KEEP ON RESTARTING, CAUSING THE LOST OF DATA. EVENT 4/4. NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2072695 TABLET PC TREX HD MONITORING - REPAIRED TABLET PC TREX HD MONITORING - REPAIRED GWQ NATUS MEDICAL INCORPORATED 019761R 025269471553

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other