BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO CORPORATION

    MDR report key: 1587832 · Received January 25, 2010

    Report

    Report Number
    1051786-2010-00006
    Event Type
    Malfunction
    Date Received
    January 25, 2010
    Report Date
    September 21, 2009
    Manufacturer
    INVIVO CORPORATION
    Product Code
    DRT
    PMA / PMN Number
    K001775
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CLAIMED THAT THE DEVICE IS NOT GIVING ANY AUDIBLE ALARMS. THE CUSTOMER WAS ADVISED BY TECHNICAL SUPPORT TO CONNECT AN OSCILLOSCOPE TO THE SPEAKER CONNECTIONS AND THEN INITIATE AN ALARM CONDITION. IT THERE IS A SIGNAL ON THE OSCILLOSCOPE, THEN THE PROBLEM IS THE SPEAKER. IF THERE IS NO SIGNAL, THEN THE PROBLEM IS WITH A PCB. THE CALL NOTES INDICATE THAT THE CUSTOMER WAS GOING TO TRY THIS AND CALL BACK IF THE PROBLEM PERSISTED. THE CUSTOMER DID NOT CALL BACK. THE INVESTIGATOR CALLED THE CUSTOMER TO INQUIRE ABOUT THE OUTCOME OF THE REPORTED PROBLEM. THE CUSTOMER REPORTED THAT THEY FOUND A LOOSE CONNECTION INSIDE THE DEVICE AND WHEN THE CONNECTION WAS RESTORED, THE AUDIBLE ALARMS BEGAN WORKING AGAIN. WHEN ASKED HOW THE LOOSE CONNECTION OCCURRED, THE CUSTOMER CLAIMED THAT HE DID NOT KNOW, BUT SUSPECTED THAT IT BECAME LOOSE AS THE RESULT OF DAILY USE. THE CUSTOMER DID NOT REQUIRE ANY ADDITIONAL ASSISTANCE FROM INVIVO REGARDING THIS REPORTED PROBLEM. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MONITOR WAS NOT PROVIDING AUDIBLE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO CORPORATION ESCORT M8 PT MONITOR DRT INVIVO CORPORATION 3800S

    Patients

    Seq Age Sex Outcome Treatment
    1