BEUDAMED
    FDA Adverse Event Death Summary report: N

    FUKUDA DENSHI

    MDR report key: 2506176 · Received March 23, 2012

    Report

    Report Number
    9611031-2012-00001
    Event Type
    Death
    Date Received
    March 23, 2012
    Date of Event
    December 8, 2009
    Report Date
    March 22, 2012
    Manufacturer
    FUKUDA DENSHI CO, LTD
    Product Code
    MHX
    PMA / PMN Number
    K032290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR ORIGINAL REVIEW OF THIS EVENT WAS CLASSIFIED AS NOT A REPORTABLE EVENT PER OUR DEFINITIONS AND THE FACT THAT THE DEVICE DID NOT MALFUNCTION. DURING THE LAST FDA QSIT INSPECTION, IT WAS DETERMINED THAT OUR MDR PROCEDURES WERE NOT UPDATED TO REFLECT ALL THE DEFINITIONS OF REPORTABLE EVENTS. WE HAVE SINCE CREATED AND UPDATED OUR QA PROCEDURES AND DETERMINED THAT THIS EVENT SHOULD BE REPORTED AS IT WAS FOUND TO BE CAUSED BY HUMAN ERROR. THE (B)(6) FACILITY WAS USING A PT MONITOR WHICH WAS UNPLUGGED FROM AC POWER AND USING ONLY BATTERY POWER. IN ADDITION, THE USER HAD TURNED OFF ALL AUDIBLE ALARMS, THEREFORE, WHEN THE DEVICE ALARMED DUE TO LOW BATTERY LEVEL, THE USER WAS NOT ABLE TO HEAR. OUR DEVICE ALSO DISPLAYS THE LOW BATTERY ALARM ON THE DISPLAY BUT IT APPEARS THE USER WAS NOT IN THE ROOM AND/OR DID NOT APPEAR TO CHECK ON THE PT DURING THE TIME THAT THE BATTERY POWER WAS DIMINISHING. IF SO THEY COULD HAVE BEEN ABLE TO POSSIBLY SEE THE DISPLAY ALERTING THEM TO THIS EVEN THOUGH THE ALARMS WERE SILENCED. THIS EVENT OCCURRED ON (B)(6) 2009 AND WAS REPORTED TO US BY THE HOSPITAL TO FD ON (B)(4) 2009. FD QA INVESTIGATED AND DETERMINED IT TO BE NOT REPORTABLE AS A RESULT OF DETERMINATION OF REPORTABILITY FOR (B)(4) AND FDA ACCORDING TO OUR PROCEDURE AT THAT TIME. THE HOSPITAL FILED THEIR REQUIRED (B)(4) REPORT ON 6/22/2010 REQUESTING US TO PROVIDE REQUIRED INFO. (B)(4) RESPONDED BACK TO (B)(4) AFTER REVIEW ON JULY 7, 2010. THIS EVENT WAS DUE TO USER ERROR AND NOT DUE TO ANY MALFUNCTION OF DEVICE. (B)(4) VISITED THE CUSTOMER AND PROVIDED A THOROUGH EXPLANATION OF THE REPORT TO (B)(4) AS WELL AS EXPLANATION OF THE DEVICE OPERATION AND INSTRUCTED THEM ON THE IMPORTANCE OF ROUTINELY CHECKING THE DEVICE POWER SOURCE AS WELL AS THE IMPORTANCE OF LEAVING THE AUDIBLE ALARMS TURNED ON. IN MARCH 2012, FD QA REVISED OUR SOP'S AND MDR PROCEDURES. UPON THIS REVISION, THIS INCIDENT FALLS UNDER THE CATEGORY OF REPORTABLE EVENT HENCE THE REASON FOR THIS REPORT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS BEING ISSUED AS RESULT OF CHANGES TO COMPANY SOP'S AND DEFINITIONS OF MDR. THIS REPORTABLE EVENT WAS FOUND DURING FDA INSPECTION AND SUBSEQUENT REVIEW OF CRITICAL COMPLAINTS. IT WAS DETERMINED THAT THIS EVENT OCCURRED AS A RESULT OF USER ERROR. THIS AER IS BEING PROVIDED AS REQUESTED FROM THE WARNING LETTER ISSUED BY FDA AND AS PROMISED IN COMPANY RESPONSE TO FDA RE: CMS CASE #(B)(4). EVENT: THIS EVENT OCCURRED IN A (B)(6) HOSPITAL ON (B)(6) 2009 AND REPORTED TO US BY THE HOSPITAL ON (B)(4) 2009. THEY FILED THEIR REQUIRED PMDA REPORT DATED ON 6/1/2010; PMDA INFORMED TO US ON 6/22/2010. WE RESPONDED BACK ACCORDING TO (B)(4) PMDA REQUIREMENTS ON 7/14/2010. PT WAS A WARD UNIT AND BEING MONITORED BY A PT MONITOR. THE PT WAS FOUND EXPIRED AND NO ALARMS HAD BEEN HEARD. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE UNIT WAS UNPLUGGED FROM AC POWER AND HAD BEEN OPERATING ON BATTERY POWER ONLY. THE UNIT FINALLY DISCHARGED THE BATTERY POWER AND WAS NOT IN OPERATION. IT WAS ALSO DETERMINED THAT THE ALARMS WERE TURNED TO OFF SO THE LOW BATTERY ALARM SOUND WAS NOT HEARD EVEN THOUGH IT WAS DISPLAYED ON THE UNIT WHILE IN OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUKUDA DENSHI PATIENT MONITOR MHX FUKUDA DENSHI CO, LTD DS-7101L

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death