BEUDAMED
    FDA Adverse Event Other Summary report: N

    AESTIVA

    MDR report key: 601265 · Received May 5, 2005

    Report

    Report Number
    2112667-2005-00017
    Event Type
    Other
    Date Received
    May 5, 2005
    Date of Event
    April 14, 2005
    Report Date
    May 4, 2005
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING DIFFICULTY VENTILATING A PT DURING A CASE. DURING EACH CASE, BIOMED PERSONNEL REPORTEDLY FOUND A TWISTED SEAL WITHIN THE ABSORBER MANIFOLD. THERE WAS NO REPORTED PT INJURY. INVESTIGATION/CONCLUSION: DATEX-OHMEDA SERVICE REPRESENTATIVES PERFORMED A CHECKOUT OF THE EQUIPMENT. IT WAS REPORTED TO DATEX-OHMEDA THAT, PRIOR TO THE ALLEGED CASES, HOSPITAL PERSONNEL HAD DISASSEMBLED THE ABSORBER MANIFOLD. DURING SUBSEQUENT REASSEMBLY, IT APPEARS HOSPITAL PERSONNEL INCORRECTLY ASSEMBLED THE PARTS. INCORRECT REASSEMBLY RESULTED IN A TWISED SEAL, CREATING A LEAK IN THE SYSTEM. CORRECT MANIFOLD ASSEMBLY PROCEDURES ARE CONTAINED WITHIN THE AESTIVA OPERATION MANUAL. HOSPITAL PERSONNEL HAVE BEEN RETRAINED ON PROPER REASSEMBLY OF THE ABSORBER MANIFOLD. A PREOPERATIVE CHECK OF THE SYSTEM, AS INDICATED IN THE FDA CHECKLIST OR THAT WHICH IS CONTAINED WITHIN THE AESTIVA OPERATION MANUAL SHOULD PICK UP THE LEAK CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AESTIVA ANESTHESIA MACHINE BSZ DATEX-OHMEDA, INC. AESTIVA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR