BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1287078 · Received November 21, 2008

    Report

    Report Number
    2021710-2008-00098
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    October 4, 2008
    Report Date
    November 20, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT PROVIDE ANY PT OR DEVICE CODES ON THEIR USER FACILITY REPORT. THE FOLLOWING INFO CONCERNING THE EVAL ATTEMPT OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CARDINAL HEALTH FIELD SVC REP. THE CARDINAL HEALTH FIELD SVE REP. WENT ON SITE TO EVALUATE THE DEVICE; HOWEVER, HE WAS NOT ABLE TO EVALUATE THE DEVICE BECAUSE IT WAS SEQUESTERED BY THE HOSPITAL'S RISK MGMT AND THEY WOULD NOT RELEASE IT FOR EVAL.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED BY CARDINAL HEALTH FROM THE USER FACILITY ON 10/30/08. "OSCILLATOR SHUT OFF ON ITS OWN WHILE VENTILATING PT. PT WAS BAGGED AND SUBSEQUENTLY PLACED ON ANOTHER OSCILLATOR. PT WAS LATER TRANSFERRED TO ANOTHER FACILITY FOR HIGHER LEVEL OF CARE." "WHILE ON PT OSCILLATOR JUST SHUT DOWN, NO ALARMS WERE GOING; IT JUST "DIED". THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONDE TO A PHONE CONVERSATION WITH A USER FACILITY REP. "[NAME REMOVED] PAGED. HE WANTED TO REPORT TWO 3100A "FAILURES". I CALLED HIM BACK AND HE EXPLAINED THAT ONE "FAILED" ON A PT AND ANOTHER VENT "FAILED" DURING THE EVAL OF DUPLICATING THE ORIGINAL COMPLAINT. HE DOESN'T KNOW THE SETTINGS, BUT HE STATED THAT THERE WAS A "CIRCUIT DISCONNECTED, THE DRIVER STOPPED, AND NO ALARMS". THE PT INCIDENT HAPPENED THE FIRST WEEK OF THE SAME MONTH. I ASKED HIM FOR THE REASON IT HAS TAKEN SO LONG TO REPORT THAT INCIDENT TO US. HE STATED THAT HE DOESN'T KNOW WHY NO ONE HAS CONTACTED US. RISK MGMT SEQUESTERED THE VENT PENDING THEIR EVAL. RISK MGMT EVALUATED THEIR SECOND 3100A LAST NIGHT. THEY ONLY HAVE THESE TWO 3100AS AT THEIR FACILITY. THEY FOUND THAT AFTER "DISCONNECTING DIFFERENT TUBING", THEY COULD REPRODUCE THE INCIDENT IN WHICH NO ALARMS WOULD OCCUR. I ASKED HIM FOR THE SETTINGS. HE SAID THAT HE DIDN'T KNOW. HE STATED THAT HE BELIEVES THAT RISK MGMT WILL BE CALLING US REQUESTING A SVC DISPATCH. HE ASKED IF THE 3100A HAD ANY SOFTWARE UPDATES THAT PERHAPS THEY DID NOT RECEIVE. I EXPLAINED TO HIM THAT THERE IS NO SOFTWARE INSTALLED IN THE 3100A VENTILATORS."CARDINAL HEALTH SENT A FAX TO THE USER FACILITY SEEKING ADDITIONAL INFO CONCERNING THE REPORTED EVENT AND THE CONDITION OF THE PT. AS OF THE DATE OF THIS REPORT, THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY. THOUGH THE USER FACILITY INDICATED ON THEIR MEDWATCH REPORT THAT THE DEVICE IS AVAILABLE FOR EVAL, THE CARDINAL HEALTH FIELD SVC REP. WAS DENIED ACCESS TO THE DEVICE FOR EVAL. CARDINAL HEALTH IS WORKING THROUGH THEIR TECH SUPPORT DEPT IN ORDER TO GET THE USER FACILITY TO RELEASE THE DEVICE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS 73 LSZ VENTILATOR, HIGH FREQUENCY LSZ CARDINAL HEALTH 207, INC. 3100A *

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DAY Hospitalization| L| R