BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H12+ HOLTER RECORDER-REPAIR ONLY

    MDR report key: 23741091 · Received December 8, 2025

    Report

    Report Number
    2183461-2025-00023
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 18, 2025
    Report Date
    January 12, 2026
    Manufacturer
    MORTARA INSTRUMENT
    Product Code
    MWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE H12+ IS INDICATED FOR USE IN A CLINICAL SETTING, BY QUALIFIED MEDICAL PROFESSIONALS ONLY, FOR RECORDING ECG DATA OF PATIENTS REQUIRING AMBULATORY MONITORING. THE H12+ PROVIDES TWELVE CHANNELS OF CONTINUOUS ECG DATA TYPICALLY RECORDED OVER A 24-HOUR, 48-HOUR, OR 7-DAY PERIOD. A MINOR BURN IS DEFINED AS A BURN THAT AFFECTS ONLY THE UPPER LAYERS OF SKIN, CAUSING REDNESS AND PAIN WITHOUT DAMAGING DEEPER LAYERS. MINOR BURNS ARE TYPICALLY CLASSIFIED AS FIRST-DEGREE BURNS, WHICH CAN COVER LESS THAN 10% OF THE SKIN SURFACE IN ADULTS AND LESS THAN 5% IN CHILDREN. THEY ARE CHARACTERIZED BY RED, UNBLISTERED SKIN AND ARE OFTEN CAUSED BY SUNBURN OR BRIEF CONTACT WITH HOT SURFACES. IN THIS EVENT, THERE IS NO INDICATION THAT THE REPORTED EVENT WAS SERIOUS IN NATURE AND THERE WAS NO REPORT OF MEDICAL OR SURGICAL INTERVENTION REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, WHICH CONCLUDES A SERIOUS INJURY DID NOT OCCUR IN THIS CASE. THE EXACT CAUSE OF THE REPORTED EVENT IN UNDETERMINED AT THIS TIME AS DEVICE INSPECTION IS PENDING. HOWEVER, IF A SIMILAR EVENT WERE TO RECUR IT WOULD BE LIKELY TO CAUSE OF CONTRIBUTE TO A SERIOUS INJURY. INVESTIGATION IS ON-GOING, ALL ADDITIONAL AND RELEVANT INFORMATION RECEIVED WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR INSPECTION WHERE IT WAS DETERMINED THAT THE INTERNAL PCBA MAINBOARD WAS FAULTY. THE H12+ IS INDICATED FOR USE IN A CLINICAL SETTING, BY QUALIFIED MEDICAL PROFESSIONALS ONLY, FOR RECORDING ECG DATA OF PATIENTS REQUIRING AMBULATORY (HOLTER) MONITORING. THE H12+ PROVIDES TWELVE CHANNELS OF CONTINUOUS ECG DATA TYPICALLY RECORDED OVER A 24-HOUR, 48-HOUR, OR 7-DAY PERIOD. ALTHOUGH THERE WAS NO SERIOUS INJURY AS A RESULT OF THE REPORTED INCIDENT, IF A SIMILAR EVENT WERE TO RECUR IT WOULD BE LIKELY TO CAUSE OF CONTRIBUTE TO A SERIOUS INJURY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT AFTER PLACING A HOLTER ECG DEVICE ON AN EXTERNAL PATIENT, THE PATIENT RETURNED HALF AN HOUR LATER COMPLAINING OF BURNING SENSATIONS. WHEN EXAMINED, THE PATIENT PRESENTED SKIN REDNESS IN THE AREA UNDERNEATH THE DEVICE, AND THE DEVICE BURNED TO THE TOUCH AND WAS OFF. THE CUSTOMER ALSO NOTED THAT WHEN THEY OPENED THE DEVICE'S COVER, THE BATTERY HAD EXPLODED. THERE WAS NO REPORT OF MEDICAL INTERVENTION REQUIRED, AND NO FURTHER CLINICAL INFORMATION WAS PROVIDED BY THE CUSTOMER DURING FOLLOW-UP. DEVICE INSPECTION IS PENDING.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT AFTER PLACING A HOLTER ECG DEVICE ON AN EXTERNAL PATIENT, THE PATIENT RETURNED HALF AN HOUR LATER COMPLAINING OF BURNING SENSATIONS. WHEN EXAMINED, THE PATIENT PRESENTED SKIN REDNESS IN THE AREA UNDERNEATH THE DEVICE, AND THE DEVICE BURNED TO THE TOUCH AND WAS OFF. THE CUSTOMER ALSO NOTED THAT WHEN THEY OPENED THE DEVICE'S COVER, THE BATTERY HAD EXPLODED. THERE WAS NO REPORT OF MEDICAL INTERVENTION REQUIRED, AND NO FURTHER CLINICAL INFORMATION WAS PROVIDED BY THE CUSTOMER DURING FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2437142 H12+ HOLTER RECORDER-REPAIR ONLY ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) MWJ MORTARA INSTRUMENT H12PLUS-RO

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown