BEUDAMED
    FDA Adverse Event Death Summary report: N

    P8-2TS

    MDR report key: 24823597 · Received April 8, 2026

    Report

    Report Number
    2221819-2026-00006
    Event Type
    Death
    Date Received
    April 8, 2026
    Date of Event
    March 13, 2026
    Report Date
    May 8, 2026
    Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
    Product Code
    JOP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROBE HAS BEEN RECEIVED AND IS UNDER EVALUATION.

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE IS UNDER INVESTIGATION PENDING THE RETURN OF THE TRANSDUCER FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING USE ON A PATIENT IN CARDIAC ARREST, THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PROBE STARTED TO VIBRATE AND DID NOT GENERATE AN IMAGE. THE PROBE WAS REMOVED FROM THE PATIENT AND VISUALLY INSPECTED. NO OBVIOUS DAMAGE WAS OBSERVED AND THE PROBE CONTINUED TO VIBRATE. THE USER DISCONTINUED USE OF THE PROBE AND SWITCHED TO A TRANSTHORACIC ECHOCARDIOGRAM (TTE) PROBE TO CONTINUE ASSESSMENT OF THE PATIENT. ON 4/10/2026, IT WAS REPORTED THAT THE PATIENT EXPIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING USE ON A PATIENT IN CARDIAC ARREST, THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PROBE STARTED TO VIBRATE AND DID NOT GENERATE AN IMAGE. THE PROBE WAS REMOVED FROM THE PATIENT AND VISUALLY INSPECTED. NO OBVIOUS DAMAGE WAS OBSERVED AND THE PROBE CONTINUED TO VIBRATE. THE USER DISCONTINUED USE OF THE PROBE AND SWITCHED TO A TRANSTHORACIC ECHOCARDIOGRAM (TTE) PROBE TO CONTINUE ASSESSMENT OF THE PATIENT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497109 P8-2TS P8-2TS PHASED ARRAY TRANSDUCER(TEE) JOP SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 120-021851-00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| D