BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBM DAB (DIGITAL ACQUISITION BOX)

    MDR report key: 18490690 · Received January 11, 2024

    Report

    Report Number
    9612330-2024-00003
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Date of Event
    December 18, 2023
    Report Date
    March 8, 2024
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    OMC
    UDI-DI
    00382830010825
    PMA / PMN Number
    K093949
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT (B)(4) THE DEVICE WAS USED WITH A PATIENT FOR APPROXIMATELY 19 HOURS. THE CUSTOMER WAS GIVEN AN ADVERSE EVENT QUESTIONNAIRE TO COMPLETE AND RETURN FOR NATUS'S INVESTIGATION. THE CUSTOMER STATED THEY WILL WORK WITH THE CLINICAL HANDLER TO REVIEW AND PROVIDE ANSWERS. THE CUSTOMER WAS SHIPPED 1 OBM DAB (DIGITAL ACQUISITION BOX), SERIAL NUMBER:(B)(6) FOR EXCHANGE. RISK FILE REVIEW: DOC-013950 REV 11 OLYMPIC BRAINZ MONITOR(OBM) RISK ANALYSIS SPREADSHEET (RAS) HAZARD ID - 6.13 - INADEQUATE PACKAGING / SHIPPING SPECIFICATIONS EFFECTS (HARM): DATA LOSS. DELAYED DIAGNOSIS. THE HAZARDS IDENTIFIED HAVE BEEN REDUCED AS FAR AS POSSIBLE, AND THE RESIDUAL RISK FOR THESE HAZARDS ARE CATEGORIZED AS HAVING AN RBA RATING OF LOW DUE TO THE NATURE OF THE HAZARD. HAZARDS HAVE ASSOCIATED WARNINGS DISCLOSED IN THE IFU. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 002 REF NATUS COMPLAINT#(B)(4) UPDATE TO RISK FILE REVIEW: PER DOC-013950 REV 12 OLYMPIC BRAINZ MONITOR(OBM) RISK ANALYSIS SPREADSHEET (RAS) HAZARD ID - 5.39 - DEVICE LABEL DEPICTING ELECTRODE CONNECTION IS ATTACHED IN THE WRONG ORIENTATION. USER MISINTERPRETS DEVICE LABEL AND CONNECTS ELECTRODES SO THAT THE LEFT AND RIGHT CHANNELS ARE SWAPED EFFECTS (HARM): WRONG DIAGNOSIS WITH NO CLINICAL EFFECTS. THE HAZARDS IDENTIFIED HAVE RBA RATING OF NEGLIGIBLE AND ARE DEEMED BROADLY ACCEPTABLE. THESE RISKS HAVE BEEN REVIEWED TO DETERMINE IF ANY FURTHER CONTROL MEASURES MAY BE IMPLEMENTED SO AS TO FURTHER REDUCE THE RISK AS FAR AS POSSIBLE. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. DEVICE WAS RETURNED 08 FEBRUARY 2024 13 FEBRUARY 2024 SUSTAINING ENGINEER PROVIDED EVALUATION DETAILS - OPERATOR ERROR LEADING TO LABEL APPLIED INCORRECTLY AT CONTRACT MANUFACTURER CREATION. SCAR-000067 CREATED TO DOCUMENT ISSUE WITH THE SUPPLIER. WORK INSTRUCTIONS QMS-004738 SHOWS CORRECT ORIENTATION FOR APPLYING LABEL TO THE PRODUCT. THERE IS NO ADDITIONAL DOCUMENTED DOWNSTREAM VERIFICATION FOR CORRECT LABEL APPLICATION. LABEL AND CUTOUT WHERE LABEL IS TO BE APPLIED IS SYMMETRICAL IN SHAPE. THIS ALLOWS THE LABEL TO FIT PROPERLY INTO THE CUTOUT IN BOTH THE CORRECT AND INCORRECT ORIENTATIONS. FAILURE CONFIRMED: YES INVESTIGATION RESULT CODE: NEURO SBU/USER ERROR.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT REF NATUS COMPLAINT# (B)(4). JAN 10, 2024 -TECHNICAL SERVICE REACHED OUT TO THE CUSTOMER IN A SECOND ATTEMPT TO GET THEM TO COMPLETE THE QUESTIONNAIRE AND TO RETURN THE DEFECTIVE DEVICE. JAN 15, 2024: CUSTOMER REACHED OUT AND REPORTED THE DEVICE WAS IN FACT NOT USED WITH A PATIENT. CUSTOMER STATED THEY WILL NOT FILL OUT AND RETURN THEIR FORM. CUSTOMER CONFIRMED THEY WILL RETURN THE DATA ACQUISTION BOX. FEB 02, 2024 - AWAITING RETURN OF THE AFFECTED DEVICE FOR EVALUATION.

    Description of Event or Problem · 0

    PART OBM00002 OBM DAB (DIGITAL ACQUISITION BOX) MISLABELED. THE CUSTOMER REPORTED EXPERIENCING ISSUES WITH THEIR OBM (OLYMPIC BRAINS MONITOR) HAVING THE ELECTRODE PLACEMENT STICKER ON BACKWARDS, RESULTING IN THE ELECTRODES BEING APPLIED INCORRECTLY.

    Description of Event or Problem · 0

    PART OBM00002 OBM DAB (DIGITAL ACQUISITION BOX) MISLABELED. THE CUSTOMER REPORTED EXPERIENCING ISSUES WITH THEIR OBM (OLYMPIC BRAINS MONITOR) HAVING THE ELECTRODE PLACEMENT STICKER ON BACKWARDS, RESULTING IN THE ELECTRODES BEING APPLIED INCORRECTLY.

    Description of Event or Problem · 0

    PART OBM00002 OBM DAB (DIGITAL ACQUISITION BOX) MISLABELED. THE CUSTOMER REPORTED EXPERIENCING ISSUES WITH THEIR OBM (OLYMPIC BRAINS MONITOR) HAVING THE ELECTRODE PLACEMENT STICKER ON BACKWARDS, RESULTING IN THE ELECTRODES BEING APPLIED INCORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002351 OBM DAB (DIGITAL ACQUISITION BOX) OBM DAB (DIGITAL ACQUISITION BOX) OMC NATUS MEDICAL INCORPORATED OBM00002 00382830010825

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other