BEUDAMED
    FDA Adverse Event Death Summary report: N

    TANGO M2 STRESS BP

    MDR report key: 12294003 · Received August 9, 2021

    Report

    Report Number
    1036863-2021-00001
    Event Type
    Death
    Date Received
    August 9, 2021
    Date of Event
    June 28, 2021
    Report Date
    September 13, 2021
    Manufacturer
    SUNTECH MEDICAL, INC,
    Product Code
    DXN
    UDI-DI
    10840935105732
    PMA / PMN Number
    K122401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUNTECH HAS EVALUATED THE DEVICE AND ACCESSORIES THAT WERE RETURNED. ALL INFORMATION INDICATES THE DEVICE IS PERFORMING AS INTENDED. MICROPHONES WERE TESTED AND FOUND TO BE WITHIN TOLERANCE. THE CUFFS AND PATIENT HOSES FOUND TO HAVE NO EVIDENCE OF PHYSICAL DAMAGE. BLOOD PRESSURE READINGS TAKEN USING A BLOOD PRESSURE SIMULATOR RESULTED IN READINGS THAT WERE WITHIN ACCEPTABLE RANGES. READING STORED WITHIN THE SYSTEM'S MEMORY WERE REVIEWED AND DID NOT INDICATE ANY SYSTEM PROBLEMS.

    Description of Event or Problem · 0

    HILL ROM REPORTED TO SUNTECH THAT A PATIENT DIED WHILE UNDERGOING A STRESS TEST. THE HILL ROM STRESS TEST SYSTEM NORMALLY INCLUDES A SUNTECH TANGO M2 DEVICE. ACCORDING TO A CONVERSATION WITH BROADLAWNS, THE FOLLOWING SEQUENCE OF EVENTS OCCURRED. PATIENT CHECKED INTO THE STRESS LAB AT 14:00. STRESS TEST STARTED AT 14:28. PATIENT BECAME SHORT OF BREATH - THE STRESS TEST WAS STOPPED. AT 14:31, AN EMERGENCY CARE TEAM WITH SPECIAL EQUIPMENT AND TRAINING TO TREAT PATIENTS SUFFERING A CARDIAC ARREST WAS CALLED. THIS TEAM BEGAN ATTEMPTS TO RESUSCITATE AT 14:36. PATIENT WAS UNRESPONSIVE AT 14:55. PATIENT TIME OF DEATH WAS CALLED AT 15:32. PATIENT CAUSE OF DEATH IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    HILL-ROM, THE MANUFACTURER OF THE STRESS SYSTEM, VERBALLY REPORTED TO SUNTECH THAT A PATIENT HAD DIED WHILE UNDERGOING A STRESS TEST. SUNTECH MEDICAL HAS NOT CONFIRMED THIS EVENT NOR THE DETAILS SURROUNDING THE EVENT (E.G. PATIENT DEMOGRAPHIC INFORMATION, CAUSE OF DEATH, ETC.) DESPITE CONTACTING HILL ROM AND THE FACILITY MULTIPLE TIMES. EXCEPT FOR INITIAL INFORMATION IDENTIFYING THE TANGO M2 (SERIAL NUMBER, MODEL NUMBER, ETC), WE HAVE BEEN UNABLE TO DETERMINE HOW THE TANGO WAS USED DURING AND AFTER THE STRESS TEST AND ANY PATIENT INFORMATION. SUNTECH HAS CONTACTED HILL ROM 4 TIMES AND THE CLINIC 3 TIMES AND IN EACH CASE IT WAS DETERMINED A DIFFERENT PERSON COULD BETTER ANSWER SUNTECH'S QUESTIONS. SUNTECH HAS IDENTIFIED AND IS WORKING TO CONTACT THESE ADDITIONAL INDIVIDUALS AT HILL ROM AND THE CLINIC.

    Description of Event or Problem · 1

    HILL ROM REPORTED TO SUNTECH THAT A PATIENT DIED WHILE UNDERGOING A STRESS TEST. THE HILL ROM STRESS TEST SYSTEM NORMALLY INCLUDES A SUNTECH TANGO M2 DEVICE .PATIENT CAUSE OF DEATH AND HOW THE TANGO DEVICE WAS USED HAS NOT BEEN CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191296 TANGO M2 STRESS BP NON-INVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM DXN SUNTECH MEDICAL, INC, 2130 WO-0000002964 10840935105732

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death HILL ROM SYSTEM XSCRIBE MATERIAL NUMBER 9922-019-5| HILL ROM SYSTEM XSCRIBE MATERIAL NUMBER 9922-019-5| HILL ROM SYSTEM XSCRIBE MATERIAL NUMBER 9922-019-5