BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18119640 · Received November 13, 2023

    Report

    Report Number
    3001421318-2023-29524
    Event Type
    Malfunction
    Date Received
    November 13, 2023
    Date of Event
    February 10, 2020
    Report Date
    November 8, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT HAS BEEN REOPENED AND REVIEWED ACCORDING TO FDA FORM 483 INSPECTIONAL OBSERVATION EMS #2, EOBS2 FROM THE FDA INSPECTION CONDUCTED BETWEEN JULY 17 TO JULY 21, 2022 AT THE EMS AND BONADUZ SITES. A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG ALMOST 4 YEARS AGO, NO ATTEMPTS WILL BE PERFORMED TO OBTAIN ADDITIONAL INFORMATION. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. THIS ISSUE IS NOT DEEMED TO BE A REPORTABLE EVENT. VENTILATION IS UNPLEASANT AS A FALSE ALARM IS TRIGGERED, BUT THE VENTILATOR STILL WORKS AS SPECIFIED. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS USED. THE ROOT CAUSE WAS DETERMINED TO BE A FAULT IN SOFTWARE DESIGN SW2.8X. IN CONSEQUENCE (CORRECTION) SOFTWARE FAULT HAS BEEN FIXED IN SW 2.90. THERE WAS NO PATIENT OR USER HARM REPORTED.

    Description of Event or Problem · 0

    NEO NCPAP CONTINUES TO ACTIVATE THE APNEA ALARM, IRRESPECTIVE OF DEMONSTRATED INSPIRATORY EFFORTS OF THE PATIENT.(B)(6).RECEIVED THE FOLLOWING MESSAGE FROM OSCAR, A CLINICIAN WHO PRACTICES RESPIRATORY CARE AT ROSE MEDICAL CENTER. HE WRITES/REPORTS THE FOLLOWING: "(B)(6)., MA'AM THIS IS (B)(6).AT(B)(6).MEDICAL CENTER. I HAVE A TECHNICAL QUESTION ON ONE OF OUR G5'S IN THE NICU. IT'S ON NEO NCPAP-PS. IT'S ONLY SET TO A CPAP OF 6. IPAP IS TURNED TO 0. THE RATE IS GREYED OUT. THERE IS AN I-TIME 0.5 AND TI MAX OF 0.55. THE APNEA TIME ALARM IS OFF AND IT'S GIVING ME A RED HARD ALARM FOR APNEA. I HAVE TURNED OFF ALL OTHER ALARMS. ANY IDEAS?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236798 HAMILTON MEDICAL AG HAMILTON-G5 CBK HAMILTON MEDICAL AG HAMILTON-G5 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown