BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 4390560 · Received December 30, 2014

    Report

    Report Number
    2021710-2014-00149
    Event Type
    Malfunction
    Date Received
    December 30, 2014
    Date of Event
    November 14, 2014
    Report Date
    November 14, 2014
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOREIGN DISTRIBUTOR DETERMINED THAT THE MOST LIKELY CAUSE OF THE REPORTED EVENT WAS A FAULTY ALARM BOARD ASSEMBLY. THE FOREIGN DISTRIBUTOR WAS SHIPPED A REPLACEMENT ALARM BOARD ASSEMBLY TO REPAIR THE DEVICE AND RETURN IT TO SERVICE. CAREFUSION ISSUED A RETURN GOODS AUTHORIZATION (RGA) NUMBER TO THE FOREIGN DISTRIBUTOR FOR THE RETURN OF THE ALLEGED FAULTY ALARM BOARD ASSEMBLY FOR EVALUATION. AS OF (B)(4) 2014 THE ALLEGED FAULTY ALARM BOARD ASSEMBLY HAS NOT BEEN RECEIVED. SHOULD THE ALLEGED FAULTY ALARM BOARD ASSEMBLY BE RECEIVED AND EVALUATED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS: 3100A ALARM BOARD ASSY PN: 768588, SN: (B)(4) WAS RECEIVED AND ROUTED TO THE CAREFUSION FAILURE ANALYSIS LAB FOR EVALUATION. THE CAREFUSION FAILURE ANALYSIS LAB TECHNICIAN EVALUATED THE ALARM BOARD ASSY AND FOUND THAT ALONG WITH A CORRESPONDING AUDIBLE ALARM, THE HI PAW LED AND MIN PAW LED WERE COMING ON INTERMITTENTLY. IT WAS FOUND THAT THE OUTPUT VOLTAGE AT COMPARATOR IC U5 PIN 1 AND PIN 14 WERE GOING LOW WITH NO ALARM CONDITION CAUSES THE VENTILATOR TO DUMP ITS PATIENT CIRCUIT PRESSURE AND SHUT DOWN. THE FAILURE ANALYSIS LAB TECHNICIAN REPLACED U5 AND NOW THE VENTILATOR IS FUNCTIONING NORMALLY. FINDING/ROOT-CAUSE: DUPLICATED, UNIT DUMPS THE PATIENT CIRCUIT PRESSURE, COMPLAINT ALLEGATION. DEFECTIVE IC U5, IC-339 V COMPARATOR LOW POWER PN: 861648.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM A CAREFUSION VENTILATION COMPLAINT FORM SUBMITTED ON BEHALF OF USER FACILITY IN (B)(6) BY THE DISTRIBUTOR IN (B)(6). "AFTER BEING SET UP AND PRESSURIZED, THE OSCILLATOR WILL DUMP THE PRESSURE IMMEDIATELY OR HOLD THE PRESSURE FOR ANYTHING UP TO 20 MINUTES. REGARDLESS IF IT IS KEPT PRESSURIZED, OR OSCILLATING, IT EVENTUALLY DUMPS ALL THE PRESSURE AT ONCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858348 SENSORMEDICS VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA