BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E.M.E.

    MDR report key: 1181911 · Received September 25, 2008

    Report

    Report Number
    2021710-2008-00085
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 25, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    MNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON AUGUST 29, 2008, CARDINAL HEALTH SENT A LETTER TO THE THIRD PARTY SERVICE COMPANY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. AS OF THE DATE OF THIS REPORT, THERE HAS BEEN NO RESPONSE TO THE LETTER FROM THE THIRD PARTY SERVICE COMPANY. THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH THE THIRD PARTY SERVICE COMPANY REPRESENTATIVE. THE THIRD PARTY SERVICE COMPANY BIOMED TECH EVALUATED THE DEVICE AND IDENTIFIED ONE OR TWO DEFECTIVE CALIBRATION POTS ON PROCESSOR BOARD AT THE ROOT CAUSE OF THE REPORTED EVENT. THE THIRD PARTY SERVICE COMPANY HAS NOT REPAIRED THE DEVICE BECAUSE THE HOSPITAL IS THINKING OF REPLACING IT WITH A NEWER DEVICE. DEVICE REMAINS IN A NON-REPAIRABLE AND NON-OPERATIONAL STATUS. THE THIRD PARTY SERVICE COMPANY WAS NOT SHIPPED A REPLACEMENT COMPONENT AS NONE WAS REQUESTED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTIONS OF THE EVENT WERE DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A THIRD PARTY SERVICE COMPANY REPRESENTATIVE. IN 2008 "[NAME REMOVED] CALLED TO REPORT SOMETHING UNUSUAL. HE REPLACED THE O2 CELL AND THEN THE AUDIBLE ALARM GOES OUT. THE VISUAL ALARM IS THERE, BUT THE AUDIBLE ALARM ISN'T. THE AUDIBLE ALARM WAS PRESENT BEFORE HE REPLACED THE O2 FUEL CELL. I SUGGESTED LOOKING AT ALL CONNECTIONS AND CIRCUITRY FROM THE BUZZER AND THE CALIBRATION POTENTIOMETERS. HE MEASURED THE BUZZER AND READ 0V. I WENT THROUGH THE SCHEMATICS WITH HIM AND SUGGESTED CHECKING THE CAL POTS AS THERE IS A CONNECTION BETWEEN THE O2 CELL, POTS AND ALARM SIGNAL. HE WILL CHECK THE CONNECTIONS AGAIN BECAUSE HE DOESN'T BELIEVE THAT THE "BUZZER" WENT OUT. HE WILL CALL BACK IF HE HAS TO SEND THIS IN FOR REPAIR. (HE DOESN'T KNOW THE SERIAL NUMBER BECAUSE IT IS UNDER THE BRACKET)". ON 09/24/2008 "I CONTACTED [NAME REMOVED] PER QA'S REQUEST REGARDING COMPLAINT. [NAME REMOVED] EXPLAINS THAT HE HAS RECEIVED MULTIPLE CALLS FROM SOMEONE AND ANSWERED THEIR QUESTIONS. HE ALSO REPORTS THAT HE HAS EVEN MAILED BACK A QUESTIONAIRE THAT WAS SENT TO HIM REGARDING THE COMPLAINT. [NAME REMOVED] EXPLAINS THAT HE ISOLATED THE CAUSE TO BE ONE OR BOTH CALIBRATION POTENTIOMETERS. BECAUSE THIS UNIT IS OLD AND THE HOSPITAL IS THINKING ABOUT REPLACING IT WITH A NEWER "MODEL", HE HAS NOT REPAIRED IT. IT REMAINS IN A "NON-REPAIRABLE/NON-OPERATIONAL" STATUS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E.M.E. CONTINOUS POSITIVE AIRWAY PRESS UNIT MNT CARDINAL HEALTH 207, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA