BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    31.5072824 H207PGT ECG EL LD DIN XRAY

    MDR report key: 16341088 · Received February 9, 2023

    Report

    Report Number
    9710060-2023-00212
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    January 20, 2023
    Report Date
    April 4, 2023
    Manufacturer
    CARDINAL HEALTH
    Product Code
    DRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B3 - DESCRIBE EVENT OR PROBLEM: ADDITIONAL DETAILS PROVIDED BY THE CUSTOMER ON 2/20/23 WERE ADDED TO THE EVENT DESCRIPTION. SECTION D4 - LOT NUMBER: ADDED MANUFACTURING LOT NUMBER. SECTIONH6 - MEDICAL DEVICE PROBLEM CODE: ORIGINALLY CODED AS 1543 (INCORRECT INTERPRETATION OF SIGNAL) UPDATED TO CODE 1581 (FAILURE TO READ INPUT SIGNAL).

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. NINETEEN PHYSICAL SAMPLES WERE RETURNED FOR INVESTIGATION. FOR PRODUCT ANALYSIS THE TESTING WAS CONDUCTED TO EVALUATE INSPECTION PROCEDURES BY A VISUAL INSPECTION AND ALL REQUIREMENTS FULFILLED. ALL PARTS EXISTING, NOTHING DAMAGED AND REQUIREMENTS WERE FULFILLED. A T-PEEL TEST 180° RESULTS WERE THAT THE ADHERENCE PERFORMANCE WAS WITHIN SPECIFICATION. A WEAR ON HUMAN SKIN WAS PERFORMED ON TWO VOLUNTEERS. THE ADHERENCE ON SKIN WAS WITHIN SPECIFICATION, NONE OF THE ELECTRODES WERE DETACHING, AND NO SKIN IRRITATIONS WERE OBSERVED. THE RESULTS OF THE PRODUCT ANALYSIS DID NOT SHOW THE DESCRIBED ISSUES THEREFORE THE TRUE ROOT CAUSE OF THE ISSUES COULD NOT BE DETECTED. THE MOST PROBABLE ROOT CAUSE IS THAT THE INDIVIDUAL SKIN CONDITION OR SKIN PREPARATION OF THE PATIENT CAUSED A LOWER ADHESION AS IT WAS RECOGNIZED BY THE CUSTOMER. AS THE TRUE ROOT CAUSE COULD NOT BE DETERMINED NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THIS COMPLAINT WILL BE RECORDED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON 2/20/23, STATED THAT MORE THAN ONCE, A NEW SET WAS PULLED HOWEVER IT WAS NOT POSSIBLE TO GET A CLEAR AND SUITABLE EKG DETECTION FOR IDENTIFICATION OF RETURN TO NORMAL CIRCULATION (ROSC). THE ROSC WAS CONFIRMED WITH AN ULTRASOUND TECHNIQUE. THE PATIENT WAS ABLE TO BE RESUSCITATED WITHOUT ANY ECG MONITOR AID. THE ACTUAL CAUSES OF THIS ACUTE CARDIOVASCULAR EVENT ARE STILL UNDER INVESTIGATION; THE NEWBORN WAS BORN AFTER A CESAREAN SECTION AT 34+5 GW (EARLY PRETERM) DUE TO THE STATUS OF THE MOTHER WHO EXPERIENCED INFLAMMATORY & SYSTEMIC SEPTIC. SO FAR, THE PATIENT¿S STATUS IS COMPATIBLE WITH HYPOXIC ISCHEMIC ENCEPHALOPATHY; THE ACTUAL OUTCOME CANNOT BE DETERMINED RIGHT NOW.

    Description of Event or Problem · 0

    CUSTOMER REPORTS: THE ECG TRACING DETECTION WAS ALTERED DUE TO POOR SKIN ADHERENCE, UNEXPECTED WORSENING AND SERIOUS DANGER. CONSEQUENCES WERE THAT THE ABSENCE OF A RELIABLE ECG TRACING DETECTION OCCURRED DURING CARDIOPULMONARY RESUSCITATION IN A CRITICALLY ILL INFANT DESPITE THE DEVICE REPOSITIONING OR DEVICE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168842 31.5072824 H207PGT ECG EL LD DIN XRAY ELECTRODE, ELECTROCARDIOGRAPH DRX CARDINAL HEALTH 31.5072824 22167C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown