BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITI 70

    MDR report key: 11366631 · Received February 23, 2021

    Report

    Report Number
    3019216-2021-10023
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    February 10, 2021
    Product Code
    IYN
    UDI-DI
    00884838056251
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED BY PRODUCT ENGINEERING TO ASSESS THE REPORTED ISSUE. DUE TO THE HAZARDOUS CONDITION OF THE FAILED BATTERY AND THE SHIPPING RESTRICTIONS FOR DAMAGED/DEFECTIVE LITHIUM BATTERIES, THE DEVICE COULD NOT BE RETURNED TO NORTH AMERICA FOR A DETAILED FAILURE ANALYSIS FROM PHILIPS OR THE SUPPLIER. HOWEVER, VISUAL INSPECTION FROM PHOTOGRAPHS OF THE DAMAGED BATTERY BY PHILIPS ELECTRICAL ENGINEERING CONFIRMED THE ISSUE UNDERWENT THERMAL RUNAWAY. THERMAL RUNAWAY IS AN EXTREMELY RARE EVENT CAUSED BY SEVERAL POSSIBLE FLAWS WITHIN A CELL WHICH CAUSES A REACTION THAT SPREADS TO THE OTHER CELLS IN THE BATTERY. WHEN THIS UNAVOIDABLE ISSUE DOES OCCUR, THE BATTERY IS CONTAINED IN A METAL ENCLOSURE BEHIND A PLASTIC SHROUD THAT PROTECTS PATIENTS AND USERS FROM CONTACT WITH THE FAILED BATTERY.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. RESULTS OF THE INVESTIGATION WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS COMPLETION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED ENCOUNTERING AN INCIDENT WHERE A LITHIUM ION BATTERY FAILED WITHIN THEIR AFFINITI ULTRASOUND SYSTEM. A SERVICE ENGINEER IDENTIFIED A BURNT BATTERY PACK WHICH ALSO CAUSED DAMAGE TO THE POWER SUPPLY. THIS FAILURE OCCURRED DURING THE NIGHT SHIFT WHERE THE SYSTEM WAS IN STANDBY AND NOT IN USE. THERE WAS NO REPORT OF HARM, INJURY OR PROPERTY DAMAGE AS A RESULT OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263737 AFFINITI 70 SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN AFFINITI 70 DIAGNOSTIC ULTRASOUND SYSTEM 00884838056251

    Patients

    Seq Age Sex Outcome Treatment
    1