BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ARKON ANESTHESIA WORKSTATION

    MDR report key: 5088750 · Received September 18, 2015

    Report

    Report Number
    9611295-2015-00008
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Date of Event
    January 30, 2015
    Report Date
    September 18, 2015
    Manufacturer
    SPACELABS HEALTHCARE LTD.
    Product Code
    CBK
    PMA / PMN Number
    K113051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SENT TO CORRECT THE MANUFACTURER INFORMATION. THE OLD REPORT NUMBER WAS 3010157426-2015-00024. ONSITE INVESTIGATION BY A SPACELABS FIELD SERVICE ENGINEER (FSE) CONFIRMED THE CO2 CANISTER SEAL HAD BEEN REMOVED AND IMPROPERLY RE-INSTALLED CAUSING A LEAK. WHEN THE CANISTER CONTENTS ARE REPLACED, THE SEAL MUST BE REINSTALLED AS PART OF ROUTINE USE. THE FSE CORRECTLY INSTALLED THE SEAL WHICH RESOLVED THE ISSUE. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE CLOSED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SENT TO CORRECT THE MANUFACTURER INFORMATION. THE OLD REPORT NUMBER WAS 3010157426-2015-00024. ONSITE INVESTIGATION BY A SPACELABS FIELD SERVICE ENGINEER (FSE) CONFIRMED THE CO2 CANISTER SEAL HAD BEEN REMOVED AND IMPROPERLY RE-INSTALLED CAUSING A LEAK. WHEN THE CANISTER CONTENTS ARE REPLACED, THE SEAL MUST BE REINSTALLED AS PART OF ROUTINE USE. THE FSE CORRECTLY INSTALLED THE SEAL WHICH RESOLVED THE ISSUE. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE CLOSED. THIS REPORT IS BEING GENERATED AT THE DIRECTION OF FDA BECAUSE OF SUPPLEMENTAL REPORTS RECEIVED, WITH THIS MANUFACTURER REPORT NUMBER, AND NO RECORD OF AN INITIAL REPORT.  THIS MANUFACTURER REPORT IS SUBMITTED TO CORRECT A PREVIOUS REPORT, 3010157426-2014-00024, THAT MISTAKENLY IDENTIFIED THE MANUFACTURER REPORT NUMBER; AT FDA FORM 3500A TOP OF PAGE 1 AND MISTAKENLY IDENTIFIED THE MANUFACTURER BY LISTING THE MANUFACTURE¿S AFFILIATE ENTITY.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A PRESSURE LEAK OCCURRED DURING A PATIENT CASE WITH THE ARKON ANESTHESIA MACHINE ON (B)(6) 2015. NO INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620667 SPACELABS ARKON ANESTHESIA WORKSTATION ANESTHESIA WORKSTATION WITH CONTINUOUS VENTILATOR CBK SPACELABS HEALTHCARE LTD. 99999

    Patients

    Seq Age Sex Outcome Treatment
    1