BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAIN MONITOR WHT-REFURB

    MDR report key: 25157951 · Received May 13, 2026

    Report

    Report Number
    9612330-2026-00001
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 13, 2026
    Manufacturer
    NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD.
    Product Code
    OLV
    UDI-DI
    00382830002523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REFERENCE NATUS COMPLAINT# (B)(4). PER (B)(4) REV 87 XLTEK EEG PSG RAS. HAZARD 2.1 - FAILURE OF AMPLIFIER POWER SUPPLY/ TRANSFORMER. EFFECT (HARM): FIRE - SMOKE INHALATION, SECOND DEGREE BURNS, THIRD DEGREE BURNS. RESIDUAL RISK: MEDIUM. THE HAZARDS IDENTIFIED HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH A KNOWN STANDARD. AS NOTED IN QMS-000018, HAZARDS THAT HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH KNOWN STANDARDS CAN BE PRESUMED TO BE CONSISTENT WITH AN ACCEPTABLE LEVEL OF RISK, YIELDING AN ACCEPTABLE RISK / BENEFIT TO THE PATIENT OR USER. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. INVESTIGATION RESULTS: THE POWER CORD PLUG WAS EVALUATED BY NATUS ENGINEERING BY VISUAL INSPECTION; THE FAILURE APPEARS TO BE RELATED TO WEAR AND TEAR. THE POWER CORD PLUG IS AN OLDER POWERVAR DESIGN, WHICH WAS ENHANCED IN 2024 FROM AN ASSEMBLE PLUG TO A MOLDED PLUG, MAKING THE CORD MORE ROBUST. ROOT CAUSE/PROBABLE ROOT CAUSE: WEAR AND TEAR, THE PLUG USED IN THIS INSTANCE WAS THE PRIOR ASSEMBLED PLUG DESIGN AND IS BEYOND THE 5-YEAR WARRANTY PERIOD PROVIDED BY THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REFERENCE NATUS COMPLAINT# (B)(4). PER (B)(4) REV 87 XLTEK EEG PSG RAS. HAZARD 2.1 - FAILURE OF AMPLIFIER POWER SUPPLY/ TRANSFORMER. EFFECT (HARM): FIRE - SMOKE INHALATION, SECOND DEGREE BURNS, THIRD DEGREE BURNS. RESIDUAL RISK: MEDIUM THE HAZARDS IDENTIFIED HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH A KNOWN STANDARD. AS NOTED IN QMS-000018, HAZARDS THAT HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH KNOWN STANDARDS CAN BE PRESUMED TO BE CONSISTENT WITH AN ACCEPTABLE LEVEL OF RISK, YIELDING AN ACCEPTABLE RISK / BENEFIT TO THE PATIENT OR USER. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. THE CUSTOMER REPORTED THE POWER CORD CAUGHT FIRE. THERE WAS NO INJURY, NO ENVIRONMENTAL HAZARD. THE CUSTOMER PROVIDED PICTURES OF THE AFFECTED PART. THE UNIT IS END OF LIFE. THE CUSTOMER HAS BEEN REQUESTED TO RETURN THE UNIT FOR EVALUATION. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Description of Event or Problem · 0

    POWER CORD/PLUG FROM THE UPS CAUGHT FIRE. IT HAS SCORCH MARKS AND MELTING AROUND THE CORD. NO INJURIES.

    Description of Event or Problem · 0

    POWER CORD/PLUG FROM THE UPS CAUGHT FIRE. IT HAS SCORCH MARKS AND MELTING AROUND THE CORD. NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137744 BRAIN MONITOR WHT-REFURB BRAIN MONITOR WHT-REFURB OLV NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. 10388-R 00382830002523

    Patients

    Seq Age Sex Outcome Treatment
    1