BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 2192593 · Received July 1, 2011

    Report

    Report Number
    2021710-2011-00046
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. THE ALLEGED FAULTY ALARM BOARD ASSEMBLY WAS RECEIVED BY CAREFUSION ON (B)(4) 2011, ROUTED TO THE CAREFUSION FAILURE ANALYSIS LAB AND STAGED FOR EVAL. ONCE THE EVAL IS COMPLETE A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. A REVIEW OF THE CAREFUSION COMPLAINT SYSTEM FOR THE PAST 90 DAYS RESULTED IN ZERO LIKE FAILURES, THUS AT PRESENT CAREFUSION CONSIDERS THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. "[NAME REMOVED] CALLED TO REPORT THAT HE FOUND THAT THE ALARMS DO NOT ACTIVATE PER SPECS. THE END-USERS NOTICED THIS WHILE SETTING THE VENT UP. WHEN THEY SET THEIR MAX PAW ALARM, THEY NOTICED THAT THEY HAD TO SET IT HIGHER THAN THEY WANT TO SO THAT THE UNIT WOULDN'T ALARM (VISUAL). THE AUDIBLE ALARM WOULD ONLY COME ON WHEN THE UNIT IS SHUT OFF. ALTHOUGH HE IS NOT FACTORY TRAINED, HE DID EVALUATE THE VENT AND VERIFIED THE COMPLAINT. HE COULD SET AN ALARM CONDITION AND THE VISUAL ALARM WOULD BE PRESENT, BUT THERE WAS NO AUDIBLE ALARM. SINCE THE AUDIBLE ALARM DID COME ON WHEN THE VENT WAS SHUT DOWN, HE FEELS THAT THE SPEAKER IS WORKING. I SUGGESTED REPLACING THE ALARM BOARD (B)(4) AS IT SOUNDS LIKE THE RELAY FROM THE MAP PANELMETER TO THE BOARD IS NOT WORKING. ALTHOUGH THE FACTORY TRAINED PERSON IS NO LONGER AT THIS FACILITY, I WILL SEND A REPLACEMENT ALARM BOARD SO THAT (B)(6) CAN REPLACE IT. I SUGGESTED GOING THROUGH THE ALARM FUNCTION CHECK OUT AND TO CALL US IF HE WANTED A SERVICE CALL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS VENTILATOR, HIGH FREQUENCY/LSZ LSZ CAREFUSION CORP. 3100A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA