BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18872036 · Received March 10, 2024

    Report

    Report Number
    3001421318-2023-41384
    Event Type
    Malfunction
    Date Received
    March 10, 2024
    Date of Event
    December 12, 2022
    Report Date
    March 9, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K121225
    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 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 USED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE ESM BOARD. IN CONSEQUENCE THE ESM BOARD WAS REPLACED. THERE WAS NO PATIENT OR USER HARM REPORTED.

    Description of Event or Problem · 0

    THE DEVICE WOULD NOT COMPLETE THE BOOT PROCESS; SO I WAS NOT ABLE TO DOWNLOAD A TECHNICAL STATE. REPLACEMENT OF THE ESM BOARD RESOLVED THE ISSUE; AND THE DEVICE NOW COMPLETES THE BOOT PROCESS. FROM: 160206:06:018665 TO MSP160206:11:54548. THE DEVICE WOULD ONLY POWER ON WITH BATTERY POWER; AC POWER WAS NOT RECOGNIZED BY THE DEVICE; REPLACEMENT OF THE POWER SUPPLY RESOLVED THE ISSUE AND DEVICE NOW POWERS ON WITH AC POWER AND AC POWER IS RECOGNIZED BY THE DEVICE. FROM: 369199:01:C2321E0022 TO MSP160600:04: TNM0640048. AFTER THE SOFTWARE UPDATE TO 2.2.5 A TF431002 BLOWER DISCONNECT SHOWED UP FOR SOME REASON BUT REPLACEMENT OF THE BLOWER RESOLVED THE ISSUE AND TF431002 WENT AWAY. FROM: 160250:06:23552 TO MSP160250:06:33903. SERVICE SOFTWARE AND FUNCTION CHECKS ALL PASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157016 HAMILTON MEDICAL AG HAMILTON-C2 CBK HAMILTON MEDICAL AG HAMILTON-C2 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown