BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1368561 · Received April 17, 2009

    Report

    Report Number
    2021710-2009-00014
    Event Type
    Malfunction
    Date Received
    April 17, 2009
    Date of Event
    February 19, 2009
    Report Date
    April 16, 2009
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE CUSTOMER'S INVESTIGATION AND EVAL THEY DISCOVERED THAT THE UNIT WAS OPERATING AS INTENDED AND THE ALLEGED FAILURE WAS CAUSED BY A DEFECTIVE CAP. DIAPHRAGM WHICH IS A COMPONENT USED ON THE 3100B (HFOV) PT'S CIRCUIT. THE CUSTOMER IDENTIFIED THAT THE DEFECTIVE CAP/DIAPHRAGM WAS FROM LOT # 052308. THIRTEEN BOXES OF CAP/DIAPHRAGMS (LOT # 052308) WERE RETURNED TO CARDINAL HEALTH FOR EVAL. PER CUSTOMER, THE UNIT WAS OPERATING AS INTENDED. UPON RECEIPT AT THE FACTORY, THE CARDINAL HEALTH FAILURE ANALYSIS LAB TECHNICIAN RAN THE CAP/DIAPHRAGMS (LOT # 052308) ON A TEST 3100B (HFOV) AND WAS NOT ABLE TO REPRODUCE THE REPORTED FAILURE THUS WAS NOT ABLE TO IDENTIFY A ROOT CAUSE IN THIS ALLEGED EVENT. A REVIEW OF TRENDED COMPLAINTS FOR THE PAST 6 MONTHS DOES NOT REVEAL A TREND ASSOCIATED WITH CAP/DIAPHRAGMS, AT PRESENT THIS EVENT IS CONSIDERED TO BE AN ISOLATED INCIDENT. ADDITIONALLY, THIS FILE WILL BE TRENDED AS PART OF OUR MONTHLY TRENDING. REPLACEMENT CAP/DIAPHRAGMS WERE SENT TO THE CUSTOMER ON SALES ORDER.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM THE USER FACILITY MED WATCH REPORT RECEIVED BY CARDINAL HEALTH MEDICAL PRODUCTS FROM THE FDA ON 03/20/2009, AND THEN FORWARDED TO CARDINAL HEALTH, INC ON 03/23/2009. "EVENT DESC: WHILE VENTILATING PT ON HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV) THE MEAN AIRWAY PRESSURE (MAP) ACUTELY INCREASED FROM 28 TO 40CMH2O PRESSURE. THERE WAS NO OBVIOUS REASON FOR THIS; HOWEVER, THE PROPER ADJUSTMENTS WERE IMMEDIATELY (WITHIN SECONDS) MADE TO RETURN THE PT TO THE DESIRED MAP. THE PT SUFFERED NO HARM AS A RESULT OF THIS INCIDENT, AND THE EQUIPMENT INVOLVED WAS SAVED AND GIVEN TO THE PROPER DEPARTMENT PERSONNEL FOR FOLLOW-UP INVESTIGATION AND EVALUATION."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR