BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C3

    MDR report key: 18108719 · Received November 10, 2023

    Report

    Report Number
    3001421318-2023-11294
    Event Type
    Malfunction
    Date Received
    November 10, 2023
    Date of Event
    August 31, 2022
    Report Date
    August 30, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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 2 YEARS AGO, NO ATTEMPTS WILL BE PERFORMED TO OBTAIN ADDITIONAL INFORMATION. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. IN FUTURE HAMILTON MEDICAL AG WILL REPORT AN EVENT SIMILAR TO THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT. 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 NOT USED. THE ROOT CAUSE WAS DETERMINED TO BE A O2 CELL EXPIRATION DATE REACHED, O2 MIXER ASSEMBLY WAS DEFECTIVE. IN CONSEQUENCE, AS PER THE RGAS THE FOLLOWING ITEMS WERE REPLACED: · MAINBOARD · FDC TO DISPLAY. · CABLE TO O2 CELL. · O2 MIXER ASSEMBLY SENSIRION. ALL TSW CALIBRATIONS WERE CARRIED OUT AND THE UNIT WAS WORKING PROPERLY. THERE WAS NO PATIENT OR USER HARM.

    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 2 YEARS AGO, NO ATTEMPTS WILL BE PERFORMED TO OBTAIN ADDITIONAL INFORMATION. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. IN FUTURE HAMILTON MEDICAL AG WILL REPORT AN EVENT SIMILAR TO THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT. 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 NOT USED. THE ROOT CAUSE WAS DETERMINED TO BE A O2 CELL EXPIRATION DATE REACHED, O2 MIXER ASSEMBLY WAS DEFECTIVE. IN CONSEQUENCE, AS PER THE RGAS THE FOLLOWING ITEMS WERE REPLACED: · MAINBOARD · FDC TO DISPLAY. · CABLE TO O2 CELL. · O2 MIXER ASSEMBLY SENSIRION. ALL TSW CALIBRATIONS WERE CARRIED OUT AND THE UNIT WAS WORKING PROPERLY. THERE WAS NO PATIENT OR USER HARM. ------------------------------------------------------------------------ HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION AS REQUESTED. UPDATED FIELDS: B4, D1, D3, D4, G1, G3, G6, H2, H4

    Description of Event or Problem · 0

    DEAR MILAD, A CUSTOMER HAD A PROBLEM WITH AN O2 CELL P.N. 396200 S.N.(B)(6): DOESN'T PASS CALIBRATION. HE REPLACED THE PART AND DID ALL THE TESTS. (B)(6) DATES: 2021-07,2022-10 B.R. ILAN OFMAN BEPEX LTD.

    Description of Event or Problem · 0

    DEAR (B)(6), A CUSTOMER HAD A PROBLEM WITH AN O2 CELL P.N. 396200 S.N. (B)(6): DOESN'T PASS CALIBRATION. HE REPLACED THE PART AND DID ALL THE TESTS. BEIT HADAR (B)(6)DATES: 2021-07,2022-10 B.R. ILAN OFMAN BEPEX LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866935 HAMILTON-C3 HAMILTON-C3 CBK HAMILTON MEDICAL AG 160005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown