BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 2840331 · Received November 6, 2012

    Report

    Report Number
    2021710-2012-00098
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    August 16, 2012
    Report Date
    August 16, 2012
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ALLEGED FAULTY CAP/DIAPHRAGMS WERE NOT RETURNED IN THEIR ORIGINAL PACKAGE THEREFORE, THE CAREFUSION FAILURE ANALYSIS LAB WAS NOT ABLE TO DETERMINE IF THEY WERE FROM LOT# 0000456327. THE CAREFUSION FAILURE ANALYSIS LAB VISUALLY INSPECTED THE RETURNED CAP/DIAPHRAGMS AND IDENTIFIED THEY ARE ASSOCIATED WITH THE KNOWN CAP/DIAPHRAGM ISSUE, THUS NO ADD'L INVESTIGATION/EVAL IS REQUIRED. CAREFUSION HAS INITIATED A SUPPLIER'S CORRECTIVE ACTION REQUEST (SCAR) TO THE SUPPLIER OF THE CAP/DIAPHRAGM ASSEMBLY AS A PART OF OUR CORRECTIVE AND PREVENTIVE ACTION SYSTEM TO ADDRESS THIS ISSUE. CAREFUSION HAS CONDUCTED A RISK ASSESSMENT RELATED TO THIS ISSUE AND HAS DETERMINED THE RISK TO BE AS LOW AS REASONABLY PRACTICABLE (ALARP). A SEPARATE MANUFACTURE MEDWATCH REPORT WILL BE SUBMITTED FOR CATALOG # 766895. REFERENCE MFR REPORT # 2021710-2012-00099.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED ON (B)(6) 2012 BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. [NAME REMOVED] CALLED AND HAS 4 BOXES WITH LOT NUMBERS THAT BEGIN WITH 456 AND 437 BOUGHT IN LAST FEW WEEKS, HE DID NOT HAVE ENTIRE LOT NUMBER AVAILABLE. THEY FAILED PT CIRCUIT CALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS VENTILATOR, HIGH FREQUENCY / LSZ LSZ CAREFUSION CAP/DIAPHRAGM SET 0000456327

    Patients

    Seq Age Sex Outcome Treatment
    1 NA