BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENDALL

    MDR report key: 22772970 · Received August 11, 2025

    Report

    Report Number
    1423537-2025-00317
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    May 30, 2025
    Report Date
    September 11, 2025
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    IKD
    UDI-DI
    20885380189262
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) FOR LOT 230228 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. THERE WERE NO PHYSICAL SAMPLES RETURNED FOR EVALUATION. HOWEVER, THE SUPPLIER TESTED A RETAINED DEVICE FROM THE REPORTED LOT NUMBER AND THE DEVICE PASSED THE TEST ACCORDINGLY. PHOTOS AND A VIDEO WERE PROVIDED FOR ANALYSIS. THE VIDEO SHOWS THAT THE USER DID NOT REFER TO THE IFU (INSTRUCTIONS FOR USE) DURING OPERATION AND FORCIBLY INSERTED THE CONNECTOR INTO THE ADAPTER IN A REVERSE DIRECTION. BASED ON THE AVAILABLE INFORMATION, THERE ARE NO CORRECTIVE ACTIONS REQUIRED AT THIS TIME. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN ALARMING PHILIPS BEDSIDE MONITOR. THE BEDSIDE MONITOR WAS DISPLAYING ONLY LEAD II AND WAS CONTINUOUSLY ALARMING WITH "ECG CHECK CABLE". IT ALSO SHOWED THAT THE PATIENT'S ECG LEAD II WAS THE ONLY LEAD THAT THE MONITOR WAS READING. ALSO, THE ECG WAVEFORM LOOKED UPSIDE DOWN AND THE PHILIPS SOFTWARE WAS READING THE RHYTHM AS "SV RHYTHM". THE CUSTOMER DISCOVERED THAT THE ECG TRUNK CABLE HAD BEEN INSERTED INCORRECTLY INTO THE MODULE/ADAPTER. ADDITIONAL INFORMATION RECEIVED ON 24JUL2025 STATED THAT THE CARDINAL ECG LEADWIRES WERE ABLE TO BE PLACED IN THE ECG ADAPTER INVERTED. THIS ALLOWS THE MONITOR TO SEE THAT THE LEADWIRES ARE PLUGGED IN BUT DISPLAYS AN INCORRECT ECG SIGNAL. ONCE THEY FLIPPED THE CABLE (INVERTED IT CORRECTLY), THE ECG STARTED READING CORRECTLY. PHOTO AND VIDEO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1903542 KENDALL CABLE, ELECTRODE IKD CARDINAL HEALTH, INC. 33561 K230228 20885380189262

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female