BEUDAMED
    FDA Adverse Event Death Summary report: N

    PEEP VALVE 20/ADPT.DISP. 20PCS

    MDR report key: 19048034 · Received April 4, 2024

    Report

    Report Number
    1220828-2024-00003
    Event Type
    Death
    Date Received
    April 4, 2024
    Date of Event
    March 4, 2024
    Report Date
    April 3, 2024
    Manufacturer
    AMBU A/S
    Product Code
    BYE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE COULD BE RETURNED FOR INVESTIGATION AS THE CUSTOMER DISPOSED THE ITEM. AMBU A/S HAS THROUGH SEVERAL ATTEMPS TRIED TO FOLLOW-UP WITH THE CUSTOMER TO CLARIFY WHETHER THE DEATH OF THE PATIENT WAS CAUSED BY OR RELATED TO THE REPORTED PRODUCT FAILURE, AND TO GET MORE INFORMATION ON THE EVENT. UNFORTUNATELY, THAT CUSTOMER HAS NOT RETURNED WITH A REPLY UNTIL THIS DATE. DURING MANUFACTURING PROCESS ALL PEEP VALVES ARE FUNCTION TESTED TO ENSURE THEY MEET DESIGN SPECIFICATION AFTER ASSEMBLING ACCORDING TO PRODUCT CONTROL PROCEDURE. AFTER REVIEW OF THE MANUFACTURING RECORDS, NO ABNORMALITIES WHICH COULD CAUSE THE REPORTED FAILURE WERE IDENTIFIED. THE PRODUCT SHOULD BE WITHIN SPECIFICATIONS. AS IT HAS NOT BEEN POSSIBLE TO RECEIVE MORE DETAILS AND INFORMATION ON THE EVENT, THE SPECIFIC FAILURE MODE COULD NOT BE DETERMINED. THEREFORE FURTHER INVESTIGATION COULD NOT BE PERFORMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE INSTRUCTION FOR USE STATES " DO NOT USE AMBU DISPOSABLE PEEP 20 VALVE IF VISILBE MOISTURE OR RESIDUES ARE LEFT INSIDE THE DEVICE IN ORDER TO AVIOD THE RISK OF INFECTION OR MALFUNCTION" AND "ALWAYS USE THE AMBU DISPOSABLE PEEP 20 VALVE WITH A MANOMETER AS THE MANOMETER ENSURES CORRECT ADJUSTMENT OF THE PEEP DURING VENTILATION. TOO HIGH OR LOW PEEP DURING VENTILATION MAY CAUSE BAROTRAUMA OR HYPOXIA, RESPECTIVELY". THIS MDR, ADDRESS ONE OF THE PRODUCT MALFUNCTIONS REPORTED FOR THIS INCIDENT (ISSUE #1). THE SECOND PRODUCT MALFUNCTION (ISSUE #2) REPORTED DURING THIS INCIDENT IS REPORTED IN MDR 1220828-2024-00004.

    Description of Event or Problem · 0

    THE PATIENT REQUIRED BAG VENTILATION FOR A CONSIDERABLE TIME DUE TO LOW OXYGEN SATURATION. DURING THIS TIME THE RT'S INVOLVED HAD SEVERAL ISSUES WITH THE PEEP VALVES. ISSUE #1: THE THERAPIST NOTICED THAT AFTER A SHORT TIME OF USE THE VALVE WAS STICKING AND NOT ALLOWING FOR ANY EXHALATION. THERE WERE USING 20 CMH2O AND NOTICED THE VALVE WAS NOT WORKING AFTER IT BECAME SLIGHTLY WET. THEY WOULD HAVE TO TAKE THE VALVE OFF AND COULD AUDIBLY HEAR THE PATIENT EXHALE BECAUSE OF THE TRAPPED GAS/AIR FROM THE VALVES NOT WORKING. (ISSUE #1 IS REPORTED IN THIS MDR). ISSUE #2: WHEN THEY DIALED THE VALVE DOWN TO 20 AND WOULD GIVE THE PATIENT A BREATH; SOME OF THE VALVES RED CAP COME OFF THE COMPLETELY. (ISSUE #2 IS REPORTED IN MDR 1220828-2024-00004). THEY WENT THROUGH 8-10 OF THESE VALVES DURING THE 2-3 HOURS OF MANUALLY VENTILATING THE PATIENT. THEY DIDN'T SAVE THE VALVES AFTER THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018084 PEEP VALVE 20/ADPT.DISP. 20PCS PEEP VALVE 20/ADPT.DISP. 20PCS BYE AMBU A/S 1000892172

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death