BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPAQ DEFIB

    MDR report key: 10982942 · Received December 10, 2020

    Report

    Report Number
    10982942
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 28, 2020
    Report Date
    December 8, 2020
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON PLACING PATIENT ON TRANSPORT MONITOR (DEFIB), HEART RATE NOTED TO BE 270 BRIEFLY, THEN 160. PROVIDER NOTIFIED TO EVALUATE PATIENT. PATIENT'S ASSESSMENT REMAINED UNCHANGED. EKG PERFORMED AND DURING IT, TRANSPORTS MONITOR SHOWED HEART RATE OF 300. EKG CAPTURED HEART RATE OF 150 AND HEART TONES AUSCULTATED IN 150S. TACHYCARDIA DETERMINED TO BE DUE TO EQUIPMENT MALFUNCTION. MONITOR CONTINUED TO DOUBLE COUNT HEART RATE IN ALL LEADS. LEADS DISCONNECTED AND HEART RATE MONITORED VIA SAT PROBE FOR TRANSPORT. MONITOR TAKEN OUT OF SERVICES. WORK ORDER PLACED TO HAVE EQUIPMENT EVALUATED. REMOVED FROM SERVICE AND CURRENTLY IN BIO-MED ENGINEERING. NOTES: DEFECTIVE ECG CABLE. CABLE IS WORN AND IS CAUSING NOISE IN THE ECG SIGNALS. ORDERING NEW CABLE, BUT WE ARE HAVING ISSUES ORDERING THE CORRECT ONE BECAUSE THE ORIGINAL CABLE IS NOT AVAILABLE. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453913 PROPAQ DEFIB AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ ZOLL MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 DA