BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 9511881 · Received December 23, 2019

    Report

    Report Number
    1218950-2019-09675
    Event Type
    Injury
    Date Received
    December 23, 2019
    Date of Event
    December 1, 2019
    Report Date
    December 12, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    UDI-DI
    00884838023680
    PMA / PMN Number
    K110825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    H.10. PATIENT INFORMATION WAS NOT PROVIDED AS THE CUSTOMER DID NOT DISCLOSE DUE TO PATIENT INFORMATION PROTECTION LAW. H.10. SERIAL NUMBER HAS BEEN UPDATED FROM BLANK TO (B)(6). H.10. INSTITUTION HAS BEEN UPDATED FROM FUKUDA DENSHI CO LTD TO MORIGUCHI KEIJINKAI HOSPITAL. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT A VT (VENTRICULAR TACHYCARDIA) WAVEFORM DISAPPEARED DURING AED ANALYSIS. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY AS REPORTED MALFUNCTION OCCURRED DURING AN EMERGENCY DEFIBRILLATION. THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED AN ECG WAVEFORM CONSISTENT WITH VENTRICULAR TACHYCARDIA, HOWEVER, ¿AED ANALYSIS SHOWED THAT A SHOCK WAS NOT NECESSARY¿ AT 00:11 AND 00:17. AT 4:03, AN AED ANALYSIS SHOWED THAT A SHOCK WAS ADVISED, THEN AT 4:29, THE DEVICE ANALYSIS SHOWED THAT A SHOCK WAS NOT NECESSARY. A PHILIPS REPAIR BENCH TECHNICIAN EVALUATED THE DEVICE AND WAS UNABLE TO DUPLICATE THE ISSUE. THE ACTUAL PATIENT CASE EVENT FILES WERE NOT AVAILABLE FOR PHILIPS TO REVIEW. NO PARTS WERE REPLACED. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS PLACED BACK INTO USE WITH THE CUSTOMER. PHILIPS WAS NOT ABLE TO CONFIRM THE REPORTED MALFUNCTION. BECAUSE THE PROBLEM COULD NOT BE RECREATED, THE CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A VT (VENTRICULAR TACHYCARDIA) WAVEFORM DISAPPEARED DURING AED ANALYSIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY AS REPORTED MALFUNCTION OCCURRED DURING AN EMERGENCY DEFIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303855 HEARTSTART XL+ DEFIBRILLATOR/MONITOR ALS DEFIBRILLATOR MONITOR MKJ PHILIPS MEDICAL SYSTEMS 861290 00884838023680

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening