BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX MONITOR/DEFIB

    MDR report key: 18274252 · Received December 6, 2023

    Report

    Report Number
    3030677-2023-04813
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    November 20, 2023
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838000018
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS FIELD SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART MRX MONITOR/DEFIB INDICATING THE DEVICE DOES NOT PASS THE SELF-TEST BECAUSE IT REQUESTS PNI AND CO2 CALIBRATION. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO REPORTED PATIENT IMPACT / INJURY. FIELD SERVICE ENGINEER (FSE) ONSITE CHECKED AND CALIBRATED CO2 AND PNI. AFTER CORRECTIVE MAINTENANCE, THE EQUIPMENT IS OPERATIONAL AND MEETS THE MANUFACTURER'S SPECIFICATIONS. THE NECESSARY VERIFICATIONS HAVE BEEN CARRIED OUT TO CERTIFY THE RESTORATION TO THE OPERATING CONDITIONS PRIOR TO THE BREAKDOWN. THE DEVICE WAS OPERATIONAL AFTER REPAIRS WERE COMPLETED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE EQUIPMENT DOES NOT PASS THE TEST BECAUSE IT REQUESTS PNI AND CO2 CALIBRATION. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772526 HEARTSTART MRX MONITOR/DEFIB DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3535A 00884838000018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown