BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1190606 · Received October 3, 2008

    Report

    Report Number
    2021710-2008-00086
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    September 5, 2008
    Report Date
    October 3, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. (B) (4). THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CARDIAL HEALTH TECH SUPPORT SPECIALIST, IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. THE USER FACILITY BIOMED IN CONJUNCTION WITH THE CARDINAL HEALTH TECH SUPPORT SPECIALIST DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS THAT THE DEVICE'S ALARM BOARD WAS FAULTY. THE USER FACILITY BIOMED REPLACED THE ALARM BOARD AND THAT FIXED THE PROBLEM. THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CARDINAL HEALTH FAILURE ANALYSIS LAB TECH. THE DEVICE'S ALARM BOARD ASSEMBLY WAS RECEIVED INTO THE CARDINAL HEALTH FAILURE ANALYSIS LAB FOR EVALUATION AND THE COMPLAINT WAS VERIFIED. THE CARDINAL HEALTH FAILURE ANALYSIS LAB TECH DETERMINED THAT THE ROOT CAUSE OF THE ALARM BOARD ASSEMBLY'S FAILURE WAS AN OPEN CIRCUIT ON DIODE (B) (4), PN: (B) (4). CARDINAL HEALTH HAS INITIATED AN INTERNAL CORRECTIVE ACTION REQUEST (CAR) # (B) (4) TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST, IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. "[NAME REMOVED] CALLED AND STATED THAT THIS UNIT IS ALWAYS DISPLAYING THE BATTERY LOW LIGHT, EVEN THOUGH HE HAS A KNOWN GOOD 9VOLT BATTERY. SINCE THE BATTERY LOW LIGHT IS ON, WHEN HE SHUTS THE UNIT OFF, THERE IS NO POWER FAILURE ALARM. EXPLAINED TO HIM THAT HE SHOULD REPLACE THE ALARM BOARD. HE UNDERSTOOD. GAVE HIM PN AND PRICE OF ALARM BOARD. HE HAS TO HAVE TO GIVE THE INFORMATION TO THE PURCHASING PEOPLE, AND HAVE THEM CALL BACK AND TO ORDER IT. EXPLAINED TO HIM THAT THEY SHOULD CALL IN AND GET THE PART THROUGH TECHNICAL SUPPORT SO THAT WE CAN ISSUE AN RGA NUMBER FOR THE DEFECTIVE BOARD. HE SAID THAT HE WOULD EXPLAIN THAT TO PURCHASING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS HIGH FREQUENCY OSCILLATORY VENT LSZ CARDINAL HEALTH 207, INC. 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA