BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18709484 · Received February 15, 2024

    Report

    Report Number
    3001421318-2023-42651
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    October 28, 2022
    Report Date
    February 14, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 (B)(6) 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 MORE THAN ONE YEAR 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 DEVICE WAS PREPARED FOR USE. THE ROOT CAUSE OF THE EVENT WAS A CRACK AROUND THE CUFF CONNECTOR AND A BROKEN USB PLUG. IN CONSEQUENCE (CORRECTION), THE INTELLICUFF STANDALONE HAS BEEN REPLACED. THERE WAS NO PATIENT OR USER HARM REPORTED.

    Description of Event or Problem · 0

    INTELLICUFF MIT ZWEI TUBUS GETESTET, DRUCK VON 25MBAR KANN NICHT GEHALTEN WERDEN, BZW. HÖRT MAN WIE DAS GERÄT NACHPUMPT UM DEN DRUCK ZU HALTEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792215 HAMILTON MEDICAL AG INTELLICUFF CBK HAMILTON MEDICAL AG INTELLICUFF 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown