BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELECTRODES, ONESTEP COMPLETE

    MDR report key: 11624400 · Received April 6, 2021

    Report

    Report Number
    1218058-2021-00041
    Event Type
    Death
    Date Received
    April 6, 2021
    Date of Event
    March 12, 2021
    Report Date
    March 16, 2021
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946016272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL MEDWATCH REPORT IS REPORTING THE EVALUATION OF THE DEVICE AND CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. THE ONESTEP COMPLETE ELECTRODES WERE RETURNED TO ZOLL MEDICAL CORPORATION ADHERED TO THE WRONG SIDE OF THE STYRENE PACKAGING. VISUAL INSPECTION THROUGH THE STYRENE LINER FOUND THE PRESENCE OF HAIR; INDICATING THEY WERE REMOVED FROM THE LINER AND USED ON A PATIENT. NO GLUE RESIDUE WAS FOUND ON THE FOAM SIDE OF THE PADS THAT WOULD HAVE CAUSED THE PADS TO STICK TO THE PACKAGING. THE PADS WERE INSPECTED AND FOUND TO BE ASSEMBLED WITHIN SPECIFICATION. THE INVESTIGATION CONCLUDED THAT THE USER RE-APPLIED THE PADS AFTER USE TO THE INCORRECT SIDE OF THE STYRENE FOR THIS SINGLE USE PRODUCT. THE PADS WERE SCRAPPED AT ZOLL. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN) IN CARDIAC ARREST, THE PADS WERE DAMAGED DURING OPENING/REMOVAL OF PACKAGING AND THEY WERE UNABLE TO ATTACH THEM TO THE PATIENT. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF PADS TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, HOWEVER IT WAS NOT A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521210 ELECTRODES, ONESTEP COMPLETE ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-0224-01 0621H 00847946016272

    Patients

    Seq Age Sex Outcome Treatment
    1 Death