BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEART START XL

    MDR report key: 12016145 · Received June 17, 2021

    Report

    Report Number
    3030677-2021-12261
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    May 21, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTING INSTITUTION PHONE: (B)(6). REPORTER PHONE: (B)(6). H3 OTHER TEXT: NO ECG MONITORING STRIPS OR CASE EVENT FILES WERE PROVIDED TO PHILIPS FOR REVIEW. THE CUSTOMER LATER CONTACTED PHILIPS AND STATED THEY CHOSE TO HAVE THE INTERVENTION CARRIED OUT INTERNALLY AND THEY REQUESTED TO CANCEL THE QUOTE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS IT WAS NOT POSSIBLE TO SHOCK THE PATIENT IN AED MODE, BUT IT WAS POSSIBLE IN MANUAL MODE. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, CAUSING A DELAY IN LIFE SAVING THERAPY AND WILL BE CONSIDERED A SERIOUS INJURY. THERE WAS NO HARM TO THE PATIENT. A QUOTE WAS SENT TO THE CUSTOMER FOR EVALUATION OF THE DEVICE. NO ECG MONITORING STRIPS OR CASE EVENT FILES WERE PROVIDED TO PHILIPS FOR REVIEW. THE CUSTOMER LATER CONTACTED PHILIPS AND STATED THEY CHOSE TO HAVE THE INTERVENTION CARRIED OUT INTERNALLY AND THEY REQUESTED TO CANCEL THE QUOTE. THE DEVICE REMAINS WITH THE CUSTOMER. NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS IT WAS NOT POSSIBLE TO SHOCK THE PATIENT IN AED MODE, BUT IT WAS POSSIBLE IN MANUAL MODE. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, CAUSING A DELAY IN LIFE SAVING THERAPY AND WILL BE CONSIDERED A SERIOUS INJURY. HOWEVER, NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915709 HEART START XL DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R