BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16310365 · Received February 7, 2023

    Report

    Report Number
    3001421318-2023-00086
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    January 16, 2023
    Report Date
    May 24, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INSPIRATORY PORT IS TOO LOOSEN: NOT ALL INFORMATION IS AVAILABLE AT THE TIME OF THIS EVALUATION. REPORTEDLY, INTERVENTION TOOK PLACE, NO PATIENT WAS HARMED. INVESTIGATION WAS INITIATED. ROOT CAUSE: INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: THE CASE CAME TO LIGHT DURING THE ANNUAL MAINTENANCE. THE AFFECTED FOAM PARTS WERE REPLACED AS SPARE PARTS, WHICH SOLVED THE PROBLEM.

    Description of Event or Problem · 0

    FOLGENDES WURDE GEMELDET AN HAMILTON MEDICAL AG: BEI DIESEM UND MINDESTENS EINEM ZWEITEN GERÄT WIRD GEMELDET, DASS DER INSPIRATIONSANSCHLUSSSTUTZEN LOCKER IST. BEIM AUFSTECKEN UND ABSTECKEN DES INSPIRATIONSSCHLAUCHS WIRD OFFENSICHTLICH DIE BODENFORM AN: 160671 DERART VERFORMT, DASS DIE KUNSTSTOFFPLATTE DES INSPIRATIONSANSCHLUSSES NICHT MEHR AUSREICHEND HALT FINDET. DIES KANN AUCH ZUM ABLÖSEN DES SCHLAUCHES ZWISCHEN DEM BLOWER UND DEM SCHLAUCHANSCHLUSSADAPTER INSPIRATIONSSEITIG FÜHREN. THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG: ON THIS AND AT LEAST ONE SECOND DEVICE, IT IS REPORTED THAT THE INSPIRATION CONNECTION PIECE IS LOOSE. WHEN ATTACHING AND DETACHING THE INSPIRATION TUBE, THE BOTTOM MOULD AN: 160671 IS APPARENTLY DEFORMED IN SUCH A WAY THAT THE PLASTIC PLATE OF THE INSPIRATION CONNECTOR NO LONGER FINDS SUFFICIENT SUPPORT. THIS CAN ALSO LEAD TO DETACHMENT OF THE HOSE BETWEEN THE BLOWER AND THE HOSE CONNECTION ADAPTER ON THE INSPIRATION SIDE. TRANSLATED WITH WWW.DEEPL.COM/TRANSLATOR (FREE VERSION).

    Description of Event or Problem · 0

    FOLGENDES WURDE GEMELDET AN HAMILTON MEDICAL AG: BEI DIESEM UND MINDESTENS EINEM ZWEITEN GERÄT WIRD GEMELDET, DASS DER INSPIRATIONSANSCHLUSSSTUTZEN LOCKER IST. BEIM AUFSTECKEN UND ABSTECKEN DES INSPIRATIONSSCHLAUCHS WIRD OFFENSICHTLICH DIE BODENFORM AN: 160671 DERART VERFORMT, DASS DIE KUNSTSTOFFPLATTE DES INSPIRATIONSANSCHLUSSES NICHT MEHR AUSREICHEND HALT FINDET. DIES KANN AUCH ZUM ABLÖSEN DES SCHLAUCHES ZWISCHEN DEM BLOWER UND DEM SCHLAUCHANSCHLUSSADAPTER INSPIRATIONSSEITIG FÜHREN. THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG: ON THIS AND AT LEAST ONE SECOND DEVICE, IT IS REPORTED THAT THE INSPIRATION CONNECTION PIECE IS LOOSE. WHEN ATTACHING AND DETACHING THE INSPIRATION TUBE, THE BOTTOM MOULD AN: 160671 IS APPARENTLY DEFORMED IN SUCH A WAY THAT THE PLASTIC PLATE OF THE INSPIRATION CONNECTOR NO LONGER FINDS SUFFICIENT SUPPORT. THIS CAN ALSO LEAD TO DETACHMENT OF THE HOSE BETWEEN THE BLOWER AND THE HOSE CONNECTION ADAPTER ON THE INSPIRATION SIDE. TRANSLATED WITH WWW.DEEPL.COM/TRANSLATOR (FREE VERSION)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107187 HAMILTON MEDICAL AG HAMILTON-C6 VENTILATOR CBK HAMILTON MEDICAL AG 160001 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown