BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX MONITOR/DEFIB

    MDR report key: 16301947 · Received February 5, 2023

    Report

    Report Number
    3030677-2023-00517
    Event Type
    Malfunction
    Date Received
    February 5, 2023
    Date of Event
    January 4, 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
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED CASES FROM THIS CUSTOMER: (B)(4): REPORTED PATIENT BURN. (B)(4): 1ST REPORT OF PADS NOT ADHERING; THIS WAS DURING A ¿CODE¿ ¿ SERIOUS INJURY. (B)(4): 2ND REPORT OF PADS NOT ADHERING; NO CODE REPORTED ¿ PRODUCT PROBLEM. (B)(4): 3RD REPORT OF PADS NOT ADHERING; NO CODE REPORTED ¿ PRODUCT PROBLEM. (B)(4): 4TH REPORT OF PADS NOT ADHERING DURING TESTING/RCA CONDUCTED BY CUSTOMER ¿ PRODUCT PROBLEM. ADDITIONAL DETAILS HAVE BEEN REQUESTED.

    Additional Manufacturer Narrative · 0

    HIS REPORT IS BASED ON INFORMATION PROVIDED BY MANAGER CLINICAL ENGINEERING AND PHILIPS SALES REPRESENTATIVE HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. THE CUSTOMER PROVIDED THE FOLLOWING INFORMATION. THE TESTING WAS COMPLETED ON A MANIKIN ENERGY SELECTED 150J DELIVERED 150J, WHEN PADS LOT 221005-4034 WERE REMOVED FROM THE MANIKIN AFTER DISCHARGING IT WAS NOTED THAT THE GEL HAD SLIGHT BUBBLING/SEPARATION, BEFORE THE PADS WERE APPLIED THE GEL LOOKED NORMAL. LOT NUMBER 220921-4032 WAS NOTED THAT THE PAD ADHESIVE DID NOT FEEL AS STICKY AS IT SHOULD BE, ENERGY SELECTED WAS EQUAL TO ENERGY DELIVERED ON THE MANIKIN. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE ISSUE WAS RELATED TO THE PADS. THE REPORTED PROBLEM WAS CONFIRMED. THE ENGINEER PROVIDED THEIR ANALYSIS FINDINGS THAT THE DEVICE PASSES ALL TESTING AND WAS PUT BACK INTO SERVICE. IT IS NOT POSSIBLE TO CONFIRM OR DETERMINE THE CAUSE OF FAILURE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. . H3 OTHER TEXT : THE CUSTOMER PROVIDED THE INFORMATION.

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS REPORT ADDRESSES ONLY ONE LOT NUMBER WHICH IS 221005-4034. THIS REPORT IS BASED ON INFORMATION PROVIDED BY MANAGER CLINICAL ENGINEERING AND PHILIPS SALES REPRESENTATIVE HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. THE CUSTOMER PROVIDED THE FOLLOWING INFORMATION. THE TESTING WAS COMPLETED ON A MANIKIN ENERGY SELECTED 150J DELIVERED 150J, WHEN PADS LOT 221005-4034 WERE REMOVED FROM THE MANIKIN AFTER DISCHARGING IT WAS NOTED THAT THE GEL HAD SLIGHT BUBBLING/SEPARATION, BEFORE THE PADS WERE APPLIED THE GEL LOOKED NORMAL. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE ISSUE WAS RELATED TO THE PADS. THE REPORTED PROBLEM WAS CONFIRMED. THE ENGINEER PROVIDED THEIR ANALYSIS FINDINGS THAT THE DEVICE PASSES ALL TESTING AND WAS PUT BACK INTO SERVICE. IT IS NOT POSSIBLE TO CONFIRM OR DETERMINE THE CAUSE OF FAILURE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. THE CUSTOMER PROVIDED THE INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SMART PADS III DID NOT ADHERE DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100379 HEARTSTART MRX MONITOR/DEFIB DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3535A 221005-4034 00884838000018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown