BEUDAMED
    FDA Adverse Event Death Summary report: N

    RP-LITE REMOTE PRESENCE SYSTEM

    MDR report key: 1991206 · Received February 8, 2011

    Report

    Report Number
    3005367513-2011-00001
    Event Type
    Death
    Date Received
    February 8, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 10, 2011
    Manufacturer
    INTOUCH TECHNOLOGIES INC.
    Product Code
    DRG
    PMA / PMN Number
    K073710
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EQUIPMENT INVOLVED IN THE REPORTED EVENT HAS BEEN SUBSEQUENTLY RETURNED TO INTOUCH TECHNOLOGIES AND IS CURRENTLY UNDER EVALUATION. AT THIS POINT IN THE EVALUATION, IT IS BELIEVED THAT THE EQUIPMENT DID MALFUNCTION, BUT THIS MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO THE SUBJECT ADVERSE EVENT. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF EQUIPMENT ANALYSIS & RECEIPT OF PATIENT INFORMATION FROM USER FACILITY.

    Description of Event or Problem · 1

    AT APPROXIMATELY 4:00 PM, ON (B)(6), 2011, A PHYSICIAN AND STROKE SPECIALIST AT HOSPITAL "1", COMMENCED A REMOTE CONSULTATIVE SESSION FOR PATIENT "A" AT HOSPITAL "2" (A SPOKE SITE OF HOSPITAL "1") USING AN INTOUCH HEALTH RP-LITE REMOTE PRESENCE SYSTEM. THE PATIENT WAS ALSO ATTENDED BY A LOCAL PHYSICIAN. APPROXIMATELY 1 MINUTE INTO A STROKE CONSULTATION, THE VISUAL CONNECTION BETWEEN THE RP-LITE AT HOSPITAL "2" AND THE CONTROL STATION AT HOSPITAL "1" WAS LOST. THE STROKE SPECIALIST THEN CONTINUED THE CONSULTATION VIA TELEPHONE, CONSISTENT WITH THE DIRECTIONS FOR USE (DFU) FOR THE RP-LITE. THE STROKE WAS DETERMINED TO BE ISCHEMIC AND A DECISION TO ADMINISTER TPA WAS MADE AND EXECUTED. DURING TRANSFER OF PATIENT TO HOSPITAL "1", THE PATIENT HEMORRHAGED AND EXPIRED. PATIENT'S CONDITION PRIOR TO THE EVENT AND OTHER INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY UNKNOWN PENDING RECEIPT OF MEDICAL RECORD AND CASE SUMMARY FROM HOSPITAL(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RP-LITE REMOTE PRESENCE SYSTEM DRG INTOUCH TECHNOLOGIES INC. RP-LITE 2632

    Patients

    Seq Age Sex Outcome Treatment
    1 Death