BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITORING

    MDR report key: 2083389 · Received April 22, 2011

    Report

    Report Number
    2520313-2011-00009
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 25, 2011
    Manufacturer
    MEDRAD, INC.
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDRAD QUALITY ASSURANCE PRODUCT ANALYSIS EVALUATED THE RETURNED ECG MODULE AND BOTH CHARGERS. THE CHARGING SYS FOR THE ECG MODULE CONSISTS OF THE BATTERY PACK AND THE CHARGER. EXAMINATION AND TESTING OF THE CHARGERS DETERMINED THAT THEY DID NOT CONTRIBUTE TO THE REPORTED INCIDENT. A VISUAL EXAMINATION OF THE ECG MODULE FOUND IT TO BE SEVERELY DAMAGED, CONSISTENT WITH THE REPORTED EVENT. ALL ASSEMBLY COMPONENTS SUSTAINED HEAT DAMAGE. THE BATTERY PACK WHICH CONSISTS OF FOUR POWER CELLS AND PROTECTION CIRCUITRY SHOWED SIGNIFICANT DAMAGE. BASED ON A REVIEW OF THE CHARGE PROTECTION DESIGN, THE SITE REPORT, AND THE EXAMINATION OF THE RETURNED EQUIPMENT, THE PROBLEM OCCURRED WHEN AN INTERNAL STRUCTURAL FAULT IN ONE OF THE BATTERY CELLS ALLOWED THE RAPID RELEASE OF STORED ELECTRICAL ENERGY. THE SITE REPORTED THAT THE ECG MODULE WAS CHARGED JUST PRIOR THE EVENT; THEREFORE, THE STORED ENERGY OF THE BATTERY WAS AT MAXIMUM CAPACITY, WHICH LIKELY EXPLAINS THE TIMING OF THIS EVENT. THE RAPID RELEASE CONVERTED MOST OF THE STORED ELECTRICAL ENERGY TO HEAT WHICH LED TO COMBUSTION. THE INTERNAL PRESSURE CAUSED THE RUPTURE OF THE CELL CONTAINER. THE RELEASED THERMAL ENERGY DAMAGED THE ADJACENT CELLS AND THE OTHER COMPONENTS OF THE ECG MODULE. THIS FAULT WAS LIKELY CAUSED BY EITHER MFG VARIATION, DEGRADATION DUE TO THE AGE OF THE CELL, OR DAMAGE SUSTAINED DUE TO AN IMPACT EXPERIENCED DURING THE LIFE OF THE UNIT. REVIEW OF THE COMPLAINT HISTORY FROM THE BEGINNING OF THE PRODUCT LIFE CYCLE DETERMINED THAT THIS WAS AN ISOLATED EVENT. WE REQUESTED THAT A THIRD PARTY TESTING FACILITY PERFORM ADD'L TESTING TO DETERMINE THE ROOT CAUSE OF THE INTERNAL STRUCTURAL FAULT. THIS TESTING IS STILL PENDING.

    Description of Event or Problem · 1

    ON APRIL 6, 2011, WE REC'D A COPY OF THE MEDWATCH REPORT THAT THE CUSTOMER SUBMITTED TO THE FDA. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDRAD VERIS MR VITAL SIGNS MONITORING VERIS MONITOR MWI MEDRAD, INC. 3011994W

    Patients

    Seq Age Sex Outcome Treatment
    1