BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMEMS PATIENT ELECTRONIC SYSTEM

    MDR report key: 10763311 · Received October 30, 2020

    Report

    Report Number
    3004936110-2020-00655
    Event Type
    Malfunction
    Date Received
    October 30, 2020
    Date of Event
    October 9, 2020
    Report Date
    January 29, 2021
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MOM
    UDI-DI
    05414734509800
    PMA / PMN Number
    P100045
    Removal / Correction Number
    3004936110-06/01/18-001R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE I3 UNIT MODEL WITH MAIN UNIT AND ONE I3 ACCESSORIES SET WERE RETURNED. VISUAL INSPECTION OF RETURNED MATERIAL REVEALED NO DISCREPANCIES OR DISCERNIBLE DAMAGE. BOTH METHODS OF SIMULATING TAKING A READING BY SELECTING START ON THE HANDHELD SCREEN AND PRESSING THE HANDHELD KEYPAD PRODUCED ERROR # 5. A REVIEW OF THE FILE: /USR/LOCAL/GPE-CARDIOMEMS/DATA/ETC/APP-COMMON.XML IN TEXT EDITOR REVEALED THE LINE WITH ¿<READING-ERROR>¿ TAG IN THE FOLLOWING STATE: <READING-ERROR>5</READING-ERROR. THE VALUE ¿5¿ WAS CHANGED TO ¿-1¿ PER INVESTIGATION GUIDANCE. ERROR # 5 DID NOT REAPPEAR WITH EITHER METHOD OF SIMULATING TAKING A READING WHEN THE UNIT WAS REBOOTED AFTER FILE EDIT. EVALUATION OF THE COMPACT FLASH IN TERMINAL REVEALED INCORRECT OPERATING SPEED SETTING. A REVIEW OF THE DHR WAS PERFORMED FOR BATCH #6243387 AND RULED OUT THE POSSIBILITY OF A MANUFACTURING RELATED ISSUE CAUSING OR CONTRIBUTING TO THE REPORTED COMPLAINT ISSUE, AS NO NON-CONFORMANCE RELATED TO THE REPORTED ISSUE WAS FOUND IN THE BATCH RECORDS REVIEWED. THE COMPLAINT OF ¿THE PATIENT ELECTRONIC UNIT RECEIVED AN ERROR 5 MESSAGE¿ WAS CONFIRMED. DUE TO FINDING OF INCORRECT SPEED SETTING ON COMPACT FLASH, THE ROOT CAUSE WAS CONCLUDED TO BE COMPACT FLASH-ERROR 5.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS INCLUDED IN THE ERROR 5 ADVISORY NOTICE ISSUED BY ABBOTT ON 01 JUNE 2018. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ELECTRONIC UNIT RECEIVED AN ERROR 5 MESSAGE, WHICH INDICATES AN ISSUE RELATED TO TEMPERATURE AND BAROMETRIC PRESSURE. A REPLACEMENT UNIT RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227941 CARDIOMEMS PATIENT ELECTRONIC SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL CM1100 6243387 05414734509800

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR