BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO/MDE ESCORT PRISMSE PATIENT MONITOR

    MDR report key: 1935688 · Received December 2, 2010

    Report

    Report Number
    1051786-2010-00019
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Report Date
    January 5, 2010
    Manufacturer
    INVIVO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K014294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE USER FACILITY'S BIOMEDICAL ENGINEER REPORTED THAT THEY FOUND DURING PREVENTIVE MAINTENANCE THAT THE DEVICE WAS NOT PRODUCING AUDIBLE ALARMS. THE BIOMEDICAL ENGINEER CLAIMED THAT THEY HAD REPLACED THE DEVICE'S SPEAKER APPROXIMATELY 2 YEARS AGO TO RESOLVE THIS SAME AUDIO ISSUE, BUT THE REPLACEMENT SPEAKER DIDN'T CORRECT THE ISSUE. THE DEVICE MANUFACTURER HAS NO RECORD OF THIS PROBLEM HAVING BEEN PREVIOUSLY REPORTED TO THE DEVICE MANUFACTURER. THE BIOMEDICAL ENGINEER STATED THAT THE USERS HAVE BEEN USING THE DEVICE AS IS, WITHOUT AUDIBLE ALARMS. THE BIOMEDICAL ENGINEER INQUIRED ABOUT IT AND WAS PROVIDED WITH OPTIONS FOR REPAIR OF THE DEVICE AS WELL AS END OF LIFE/SUPPORT INFORMATION. THE BIOMEDICAL ENGINEER STATED THAT HE WAS GOING TO CHECK WITH THE OWNER OF THE DEVICE TO SEE IF THEY WANTED TO PURSUE THE REPAIR AND WAS GOING TO CALL THE DEVICE MANUFACTURER BACK WITH THE DETAILS. THE DEVICE MANUFACTURER FOLLOWED UP WITH THE CUSTOMER THREE DAYS LATER AND WAS ADVISED THAT THE DEVICE OWNER NO LONGER WANTS TO PURSUE THE REPAIR OF THE DEVICE. AS A RESULT, THERE HAS BEEN NO OPPORTUNITY FOR THE DEVICE MANUFACTURER TO EVALUATE THE DEVICE IN ORDER TO CONFIRM THAT AN ACTUAL MALFUNCTION HAD OCCURRED. THE DEVICE MANUFACTURER CALLED THE BIOMEDICAL ENGINEER ON (B)(6) 2010 TO INQUIRE ABOUT THE CURRENT STATUS OF THE DEVICE AND WAS ADVISED THAT THE USERS CONTINUE TO USE THE DEVICE AND ARE FULLY AWARE THAT IT DOES NOT PRODUCE AUDIBLE ALARMS. UNDER NORMAL OPERATING CONDITIONS, THE DEVICE PRODUCES SOUNDS (OTHER THAN AUDIBLE ALARMS) PRIOR TO AND DURING ACTIVE MONITORING. THESE SOUNDS INCLUDE: BEEPS DURING INITIAL POWER UP, HEART RATE QRS TONES AND KEYPAD CLICKS. IN THE EVENT OF A PROBLEM WITH THE DEVICE'S SOUND FUNCTION, THESE SOUNDS WOULD NOT BE PRODUCED. THE LACK OF THESE SOUNDS SERVES AS A REMINDER TO EACH USER OF THE CAPABILITY OF THE DEVICE (LACK OF AUDIO FUNCTION) WHEN THEY INITIATE MONITORING. THE USER CAN THEN CHOOSE TO IMPLEMENT ALTERNATE MONITORING IF WARRANTED OR TO USE THE DEVICE WITHOUT AUDIBLE FUNCTIONS. ADDITIONALLY, THE DEVICE ALLOWS USERS TO TURN OFF ALARM VOLUME OR TO TURN OFF ALARMS FOR EACH INDIVIDUAL PARAMETER. THEREFORE, THE LACK OF AUDIBLE FUNCTIONS ITSELF IS NOT CONSIDERED AS A HEALTH RISK, IF USERS ARE AWARE. BECAUSE USERS ARE AWARE (AND HAVE CHOSEN BY NON-REPAIR) THAT THE DEVICE DOES NOT PRODUCE AUDIBLE ALARMS AND BECAUSE THE LACK OF OTHER SOUNDS NORMALLY PRESENT PRIOR TO AND DURING ACTIVE MONITORING SERVES AS A REMINDER TO EACH USER OF THE CAPABILITIES OF THE DEVICE, THE DEVICE IS CONSIDERED SAFE FOR CONTINUED USE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE USER FACILITY'S BIOMEDICAL ENGINEER REPORTED THAT HE FOUND DURING PREVENTIVE MAINTENANCE THAT THE DEVICE WAS NOT PRODUCING AUDIBLE ALARMS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO/MDE ESCORT PRISMSE PATIENT MONITOR DQA INVIVO CORPORATION 20411

    Patients

    Seq Age Sex Outcome Treatment
    1