BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBU SPUR II PEDIATRIC RESUSCITATOR

    MDR report key: 22382268 · Received July 2, 2025

    Report

    Report Number
    1220828-2025-00016
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    June 4, 2025
    Report Date
    August 20, 2025
    Manufacturer
    AMBU A/S
    Product Code
    OEV
    UDI-DI
    05707480163441
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED 25TH OF JUNE 2025 BY THE AMBU INC. IN US, BUT THE SAMPLE HAS NOT BEEN INVESTIGATED BY THE INVESTIGATION TEAM IN MALAYSIA YET.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT JULY 02, 2025: THE DEVICE WAS RECEIVED 25TH OF JUNE 2025 BY THE AMBU INC. IN US, BUT THE SAMPLE HAS NOT BEEN INVESTIGATED BY THE INVESTIGATION TEAM IN MALAYSIA YET. FOLLOW UP REPORT AUGUST 20, 2025: ONE SAMPLE WAS RETURNED FOR INVESTIGATION. DURING THE INVESTIGATION IT WAS FOUND THAT THE REPORTED FAILURE OF THE SPUR II HAD A BLOCKED MANOMETER PORT, WHICH COULD BE VERIFIED BY THE RETURNED SAMPLE. NO READING WAS OBTAINED FROM THE MANOMETER WHEN APPLYING PRESSURE TO THE SPUR II BAG. THE CAUSE OF THE FAILURE HAS BEEN TRACED TO A DAMAGED TOOL PIN USED DURING THE MOLDING PROCESS OF HOUSING (INJECTION CONTROL PROCEDURE). THE BLOCKED MANOMETER PORT WAS NOT DETECTED DURING QUALITY CONTROL. TO PREVENT THIS FAILURE FROM OCCURING AGAIN, THE INJECTION CONTROL PROCEDURE FOR PATIENT VALVE HOUSING HAE BEEN UPDATED WITH A VISUAL CHECK POINT FOR THE MANOMETER PORT (DONE ON (B)(6) 2025). FURTHERMORE, THE PRODUCTION CONTROL PROCEDURE FOR SPUR II, HAS BEEN UPDATED TO ADD AN EFFICIENCY CHECK FOR THE TEST MACHINE PERFORMING THE FUNCTION TEST (DONE ON (B)(6) 2025). IN ADDITION, A CAPA (CA-000948) HAS BEEN RAISED FOR THE ISSUE. AMBU WILL KEEP MONITORING THE ISSUE AND TAKE ACTIONS AS APPROPRIATE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THERE WAS NO HOLE FOR THE MANOMETER. THE MANOMETER PORT WAS BLOCKED, RENDERING THE MANOMETER NON-FUNCTIONAL. THERE WAS NO PATIENT INVOLVEMENT AS THE DEFECT WAS OBSERVED PRIOR TO USE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THERE WAS NO HOLE FOR THE MANOMETER. THE MANOMETER PORT WAS BLOCKED, RENDERING THE MANOMETER NON-FUNCTIONAL. THERE WAS NO PATIENT INVOLVEMENT AS THE DEFECT WAS OBSERVED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2484862 AMBU SPUR II PEDIATRIC RESUSCITATOR MANUAL RESUSCITATOR OEV AMBU A/S 531600051 2000015181 05707480163441

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown