BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS MULTIGAS ANALYZER MODULE

    MDR report key: 2535718 · Received April 13, 2012

    Report

    Report Number
    3023361-2012-00016
    Event Type
    Malfunction
    Date Received
    April 13, 2012
    Date of Event
    March 29, 2012
    Report Date
    April 23, 2013
    Manufacturer
    SPACELABS MEDICAL INC.
    Product Code
    CBR
    PMA / PMN Number
    K053599
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS HAS REQUESTED THE SUBJECT DEVICE TO BE RETURNED FOR INVESTIGATION. WE ARE WAITING TO RECEIVE THE DEVICE. WE ARE ALSO COLLECTING MORE INFORMATION FROM THE DISTRIBUTOR. NO ONE HAS BEEN INJURED AS A RESULT OF THIS MALFUNCTION. WE WILL PROVIDE A SUPPLEMENTAL REPORT ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    NO ONE WAS INJURED AS A RESULT OF THIS EVENT. THE CUSTOMER CORRECTED THE COMPLAINT DESCRIPTION SAYING THE 91518 MULTIGAS ANALYZER FAILED TO TURN ON. THIS CONDITION PRECLUDES ITS USE IN A CLINICAL PROCEDURE. SPACELABS REPLACED THE SUSPECT DEVICES FOR THIS CUSTOMER AND HAVE RECEIVED NO FURTHER REPORTS OF 91518 MODULES FAILING TO TURN ON. SPACELABS CONSIDERS THIS ISSUE CLOSED. THE HOSPITAL ONLY SENT PCBA'S FOR EVALUA...

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A MULTIGAS ANALYZER MODULE HAD NO FIO2 DISPLAY ON THE SCREEN.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A MULTIGAS ANALYZER MODULE HAD NO FI02 DISPLAY ON THE SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACELABS MULTIGAS ANALYZER MODULE ANESTHESIA GAS ANALYZER MODULE CBR SPACELABS MEDICAL INC. 91518

    Patients

    Seq Age Sex Outcome Treatment
    1