BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPIRATORY VALVE SET

    MDR report key: 17969390 · Received October 19, 2023

    Report

    Report Number
    3001421318-2023-03570
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Date of Event
    August 18, 2023
    Report Date
    August 8, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002803199
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS CER (B)(4). INVESTIGATION STILL ONGOING.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS CER (B)(4). INVESTIGATION STILL ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: CER (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. ACCORDING TO LOT NO. THIS EXPI WAS PART WITH PN260170. HCE IS THE MANUFACTURER, WE DON`T HAVE ACCESS TO THEIR SYSTEM.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: · DIE COMBINATION SINGLE USE EXPIRATORY VALVE SET (PN 161189), BREATHING CIRCUITS (NOT SPECIFIED) AND A HAMILTON-T1 VENTILATOR CAUSES DURING NEONATAL TRANSPORT A EXHALATION OBSTRUCTION ALARM. REPOSITIONING OR REPLACING OF THE SINGLE USE EXPIRATORY VALVE SET (PN 161189) ACTIVATES THE ALARM AGAIN. BY REPLACING THE SINGLE USE EXPIRATORY VALVE (PN 161189) WITH A REUSABLE EXHALATION VALVE (NOT SPECIFIED) NO ALARM GETS ACTIVATED. · THIS MALFUNCTION WAS NOTICED DURING TRANSPORT OF NEONATAL PATIENTS. · THE ALARM WAS OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. ID 141018 (EXHALATION OBSTRUCTED). · THIS MALFUNCTION IS REPRODUCIBLE. THIS HAPPENED 3 TIMES BY ON AND THE SAME USER. · PATIENT INVOLVEMENT IS REPORTED. THIS OCCURRED DURING NEONATAL TRANSPORT. · THERE WAS NEED FOR MEDICAL INTERVENTION REPORTED. DURING NEONATAL TRANSPORT THE VENTILATOR DEVICE HAMILTON-T1 ALARMED AND IT WAS NEEDED TO EXCHANGE THE SINGLE USE EXPIRATORY VALVE SET HAM PN 161189 WITH A REUSABLE EXHALATION VALVE (NOT SPECIFIED). · NEITHER DELAY IN TREATMENT, HARM TO USER OR THIRD PARTY HAS BEEN REPORTED. HARM TO PATIENT IS REPORTED BUT NOT FURTHER EXPLAINED. THE INVESTIGATION IS STILL ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DIE COMBINATION SINGLE USE EXPIRATORY VALVE SET (PN 161189), BREATHING CIRCUITS (NOT SPECIFIED) AND A HAMILTON-T1 VENTILATOR CAUSES DURING NEONATAL TRANSPORT A EXHALATION OBSTRUCTION ALARM. REPOSITIONING OR REPLACING OF THE SINGLE USE EXPIRATORY VALVE SET (PN 161189) ACTIVATES THE ALARM AGAIN. BY REPLACING THE SINGLE USE EXPIRATORY VALVE (PN 161189) WITH A REUSABLE EXHALATION VALVE (NOT SPECIFIED) NO ALARM GETS ACTIVATED. THIS MALFUNCTION WAS NOTICED DURING TRANSPORT OF NEONATAL PATIENTS. THE ALARM WAS OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. ID (B)(4) (EXHALATION OBSTRUCTED). THIS MALFUNCTION IS REPRODUCIBLE. THIS HAPPENED 3 TIMES BY ON AND THE SAME USER. PATIENT INVOLVEMENT IS REPORTED. THIS OCCURRED DURING NEONATAL TRANSPORT. THERE WAS NEED FOR MEDICAL INTERVENTION REPORTED. DURING NEONATAL TRANSPORT THE VENTILATOR DEVICE HAMILTON-T1 ALARMED AND IT WAS NEEDED TO EXCHANGE THE SINGLE USE EXPIRATORY VALVE SET HAM PN 161189 WITH A REUSABLE EXHALATION VALVE (NOT SPECIFIED). NEITHER DELAY IN TREATMENT, HARM TO USER OR THIRD PARTY HAS BEEN REPORTED. HARM TO PATIENT IS REPORTED BUT NOT FURTHER EXPLAINED. THE INVESTIGATION IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739000 EXPIRATORY VALVE SET EXPIRATORY VALVE SET CBK HAMILTON MEDICAL AG 161189 1900060488 07630002803199

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown