BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZEPHR

    MDR report key: 2357937 · Received October 28, 2011

    Report

    Report Number
    2023374-2011-00001
    Event Type
    Other
    Date Received
    October 28, 2011
    Date of Event
    August 13, 2011
    Report Date
    September 7, 2011
    Manufacturer
    SANDHILL SCIENTIFIC, INC.
    Product Code
    FFX
    PMA / PMN Number
    K012232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT CLEAR HOW THE REPORTED PROBLEM COULD LEAD TO DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. (PER INSTRUCTIONS ON COMPLETING THIS FORM). IT IS NOT CLEAR HOW THE REPORTED PROBLEM IS "OTHER SERIOUS" WHICH IS DEFINED AS - "THE EVENT MAY JEOPARDIZE THE PT AND MAY REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT ONE OF THE OTHER OUTCOMES. COMPLAINT RECEIVED FROM CUSTOMER (B)(6) 2011, FROM (B)(6), RN-MEMORY CARD FAILURE WITH ONLY 2.3 MINS OF DATA INCLUDED. MEMORY CARD WAS RETURNED AND LACK OF EXTENSIVE DATA WAS OBSERVED. CARD WAS REPROGRAMMED AND TESTED WITH NO MALFUNCTION FOUND. MEMORY CARD WAS RETURNED TO THE CUSTOMER. AFTER RECEIVING MEDWATCH REPORT, CONTACT WITH (B)(6). DISCUSSION LED TO THE AGREEMENT THAT THE RECORDER SHOULD BE SENT TO SANDHILL FOR EVALUATION. A LOANER RECORDER WAS SENT TO THE CUSTOMER ON (B)(6) 2011, TO BE USED WHILE THEY SEND THEIR RECORDER FOR EVALUATION. THE RECORDER IS DUE TO ARRIVE AT THE CUSTOMER SITE (B)(6) 2011. OTHER PERTINENT INFO: TEST HAD TO BE REDONE.

    Description of Event or Problem · 1

    TITLE: XXXXX. EVENT DESC: THE RECORDER WAS IN USE FOR ABOUT 24 HOURS. IT CONTAINS A MEMORY CARD THAT RECORDS INFO THAT IS TRANSMITTED FROM SIGNALS SENT BY A CATHETER (KNOWN AS A PROBE) THAT IS IN THE PTS ESOPHAGUS. PRIOR TO THE TEST, A PROBE IS CALIBRATED. DURING THE CALIBRATION, THE RECORDER DISPLAYS THE SPECIFIC PROBE NUMBER THAT IS BEING CALIBRATED, WHICH THIS DID. THE DISPLAY ON THE RECORDER INDICATED IT WAS RECORDING WHEN THE PT LEFT AND ALSO WHEN SHE RETURNED. WHEN THE MEMORY CARD WAS CONNECTED TO THE COMPUTER, THERE WAS NO INFO ON IT, INDICATING IT DID NOT RECORD ANY SIGNALS FROM THE PROBE. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G., BROKE COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPHR RECORDER, PH IMPEDANCE FFX SANDHILL SCIENTIFIC, INC. ZEPHR

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other