BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX MONITOR/DEFIB

    MDR report key: 15678234 · Received October 27, 2022

    Report

    Report Number
    3030677-2022-04798
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Date of Event
    September 26, 2022
    Report Date
    October 27, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838000018
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    PHILIPS RECEIVED A COMPLAINT ON THE 861288 (HEARTSTART MRX MONITOR/DEFIB) INDICATING THAT THE DEVICE DISPLAYED AN ERROR MESSAGE THAT THE BATTERY REQUIRED CALIBRATION. THE CUSTOMER REQUESTED ASSISTANCE ON HOW TO PROCEED. THERE WAS NO REPORTED PATIENT IMPACT. AVAILABLE DETAILS INDICATE THAT THE CUSTOMER WAS ADVISED THAT THE DEVICE WILL PROVIDE NOTIFICATIONS FOR BATTERY CALIBRATION AS A NECESSARY PERIODIC PROCESS. EXPLANATIONS FOR IMPLEMENTING THE CALIBRATION CAN BE FOUND IN THE EQUIPMENT'S INSTRUCTIONS FOR USE. THE SERVICEMAX CASE WAS CLOSED AND THE ISSUE WAS NOTED TO BE FIXED AFTER PROVIDING THIS MAINTENANCE INFORMATION. THE CUSTOMER CONTACTED PHILIPS AGAIN AS DOCUMENTED IN CONTINUATION SERVICEMAX CASE (B)(4), ADVISING THE CALIBRATION ERROR MESSAGE WAS STILL DISPLAYED. THE CUSTOMER WAS AGAIN ADVISED TO CALIBRATE THE SYSTEM. ONCE THE CALIBRATION WAS COMPLETED, THE ERROR MESSAGE CLEARED AND THE DEVICE RETURNED TO FULL FUNCTIONALITY. THE DEVICE REMAINS AT THE CUSTOMER'S SITE. NO FURTHER ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT AN ERROR TO CALIBRATE BATTERY A IS BEING DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242127 HEARTSTART MRX MONITOR/DEFIB DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3535A 00884838000018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown