BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFFINITI 70 - 795210

    MDR report key: 9616898 · Received January 22, 2020

    Report

    Report Number
    3019216-2020-00004
    Event Type
    Death
    Date Received
    January 22, 2020
    Date of Event
    January 5, 2020
    Report Date
    January 15, 2020
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838056251
    PMA / PMN Number
    K160807
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DESIGN ENGINEERING PERFORMED A THOROUGH EVALUATION ON THE RETURNED SYSTEM. THEY COULD NOT REPRODUCE THE REPORTED PROBLEM OF A SYSTEM LOCKUP OR FREEZE WHEN SWITCHING BETWEEN C5-1 AND S5-1 TRANSDUCERS. THE SYSTEM WAS PUT THROUGH DIFFERENT THERMAL TESTING SCENARIOS AND NUMEROUS BOOT CYCLES IN WHICH NO ERRORS OR FREEZING WAS OBSERVED. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    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 INVOLVING THEIR AFFINITI ULTRASOUND SYSTEM BECOMING UNRESPONSIVE DURING AN EMERGENCY EXAM OF A PATIENT WITH A RUPTURED THORACIC ABDOMINAL AORTIC ANEURYSM. THE PATIENT ULTIMATELY EXPIRED FROM THE CONDITION. THE SYSTEM FAILURE OCCURRED WHEN ALTERNATING FROM A C5-1 TO AN S5-1 TRANSDUCER. THE SYSTEM WAS PROMPTLY RESTARTED TO REGAIN FUNCTIONALITY. THERE WAS NO ALLEGATION THAT THE SYSTEM LOCKUP LED TO THE PATIENT¿S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79934 AFFINITI 70 - 795210 SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYN PHILIPS ULTRASOUND, INC 989605416151 US918F0089 00884838056251

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death