BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU SPUR II

    MDR report key: 1750715 · Received May 13, 2010

    Report

    Report Number
    9610691-2010-00005
    Event Type
    Injury
    Date Received
    May 13, 2010
    Date of Event
    April 16, 2010
    Report Date
    May 12, 2010
    Manufacturer
    AMBU A/S
    Product Code
    BTM
    PMA / PMN Number
    K042682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO THE MFR FOR EVAL. HENCE, THE EVAL WAS BASED ON THE INFO PROVIDED IN MEDWATCH REPORT # (B)(4) RECEIVED BY AMBU INC ON MAY 7, 2010 AND SUBSEQUENT COMMUNICATIONS WITH THE HOSPITAL STAFF AND AMBU REPRESENTATIVES. THIS PRODUCT DOES NOT COME WITH A MANOMETER. THE MEDWATCH REPORT DOES NOT LIST THE MFR FOR THE REUSABLE MANOMETER THAT WAS USED. THE STAFF REPORTED THAT THEY WERE CUTTING THE TIP OFF OF THEIR PORTABLE MANOMETER TO ATTEMPT TO MAKE IT FIT ON THE SPUR II MANOMETER PORT THAT IS SPECIFIC TO AMBU'S MANOMETER. THE AMBU DISPOSABLE PRESSURE MANOMETER IS DESCRIBED AS AN ACCESSORY IN THE AMBU SPUR II INSTRUCTIONS FOR USE. WE THEREFORE CONCLUDE THAT THE STAFF FAILED TO FOLLOW THE PROVIDED INSTRUCTIONS FOR USE AND THAT THE INCIDENT WAS CAUSED BY AN ATTEMPT TO USE INCOMPATIBLE DEVICES.

    Description of Event or Problem · 1

    WHILE PROVIDING POSITIVE PRESSURE VENTILATION TO AN INFANT, INADEQUATE PRESSURE WAS NOTED ON THE MANOMETER WITH INADEQUATE RISE AND FALL OF CHEST EVEN AFTER MULTIPLE ATTEMPTS IN REPOSITIONING THE INFANT. THE POP OFF VALVE WAS OCCLUDED THE HIGHEST PRESSURE ON MANOMETER WAS 8-10 CM WATER (H2O). THE INFANT WAS SUBSEQUENTLY INTUBATED. STAFF HAD ATTACHED AMBU BAG TO REUSABLE MANOMETER BY CUTTING ENDS OF TUBING. THIS IS NOT WHAT IS PROVIDED IN THE MFR'S DIRECTIONS FOR USE ON PAGE 10. THIS IS THE FIRST TIME A PROBLEM HAS BEEN NOTED WHEN THE PRODUCT HAS BEEN USED AS DESCRIBED ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU SPUR II SINGLE PATIENT USE RESUSCITATOR BTM AMBU A/S AMBU SPUR II INFANT 1108125

    Patients

    Seq Age Sex Outcome Treatment
    1 Other