BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPIC VAC-PAC

    MDR report key: 2123849 · Received May 30, 2011

    Report

    Report Number
    2123849
    Event Type
    Malfunction
    Date Received
    May 30, 2011
    Report Date
    May 30, 2011
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ROOM WAS SET UP FOR A LAPAROSCOPIC PARTIAL NEPHRECTOMY. BEAN BAG WAS PLACED ON THE OR TABLE TO POSITION THE PATIENT ON LATERAL. NURSE BROUGHT THE PATIENT TO OR. PATIENT WAS INTUBATED AND THE TEAM STARTED POSITIONING THE PATIENT. WHEN TEAM TRIED TO INFLATE THE BEAN BAG IT DID NOT INFLATE PROPERLY. TRANSFERRED THE PATIENT BACK TO STRETCHER. BROUGHT THE LATERAL POSITIONING CLAMPS AND WITH THE HELP OF THAT DEVICE AND BIG GEL ROLLS, TEAM POSITIONED THE PATIENT LATERALLY AND STARTED THE PROCEDURE.PROBLEM WAS IDENTIFIED AS A MALFUNCTION OF THE INTAKE VALVE.======================MANUFACTURER RESPONSE FOR SURGICAL POSITIONING SYSTEM, OLYMPIC VAC-PAC (PER SITE REPORTER)======================MANUFACTURER WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPIC VAC-PAC SURGICAL POSITIONING SYSTEM CCX NATUS MEDICAL INCORPORATED SIZE 30 *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR