BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 3096135 · Received April 19, 2013

    Report

    Report Number
    2021710-2013-00023
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOREIGN USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO AN E-MAIL FROM A USER FACILITY REPRESENTATIVE. (B)(4). ON (B)(4) 213 CAREFUSION ISSUED A RETURNED GOODS AUTHORIZATION (RGA) NUMBER TO THE USER FACILITY FOR THE RETURN OF THE ALLEGED FAULTY ALARM ADAPTER CABLE ASSEMBLY TO THE CAREFUSION FAILURE ANALYSIS LAB IN (B)(4) FOR EVALUATION. ADDITIONALLY, CAREFUSION SHIPPED ALARM ADAPTER CABLE ASSEMBLY USER FACILITY TO REPAIR THE DEVICE AND RETURN IT TO SERVICE. ON (B)(6) 2013 THE USER FACILITY INFORMED CAREFUSION THAT THEY ARE UNABLE TO LOCATE THE ALLEGED FAULTY ALARM ADAPTER CABLE ASSEMBLY AND MAY HAVE DISPOSED OF IT. ADDITIONALLY, THEY INDICATED THAT SHOULD THEY LOCATE IT; THEY WILL RETURN IT TO CAREFUSION. SHOULD THE ALLEGED FAULTY ALARM ADAPTER CABLE ASSEMBLY BE RECEIVED FOR EVALUATION, CAREFUSION WILL SUBMIT A FOLLOW-UP MEDWATCH REPORT. A REVIEW OF THE CAREFUSION COMPLAINT SYSTEM AND MANUFACTURING NON CONFORMANCE REPORT SYSTEM FOR THE PAST 90 DAYS RESULTED IN ZERO LIKE FAILURES, THUS 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 AN E-MAIL FROM A USER FACILITY REPRESENTATIVE. [NAME REMOVED] EMAILED REQUESTING A REPLACEMENT CABLE ASSEMBLY, ALARM ADAPTER (B)(4). SHE EXPLAINS THAT WHILE PERFORMING THE 3OHM DRIVER UPGRADE ON THIS VENTILATOR, SHE FOUND THAT THE ALARM WOULD NOT SOUND. SHE EVALUATED AND FOUND THAT THERE WAS NO VOLTAGE PASS THE RESISTOR IN THE POSITIVE LEG OF THE CABLE ASSEMBLY, ALARM ADAPTER (B)(4). EVERYTHING ELSE PASSED SPECS. THIS PAORT CAME FROM 3OHM DRIVER UPGRADE KIT (B)(4) (LOT BC001033).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169536 SENSORMEDICS VENTILATOR, HIGH FREQUENCY/LSZ LSZ CAREFUSION 3100A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA