BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 15263424 · Received August 20, 2022

    Report

    Report Number
    3001421318-2022-00039
    Event Type
    Death
    Date Received
    August 20, 2022
    Date of Event
    December 9, 2021
    Report Date
    August 20, 2022
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT STATED THE PATIENT PASSED AWAY. HOWEVER, IT REMAINED UNANSWERED IF THE DEATH WAS DEVICE RELATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOG FILES PROVIDED TO US (FROM THE DATE AND TIME OF THE EVENT) REVEALED THAT ON THE GIVEN DATE AND TIME THE EVENT DID NOT TAKE PLACE AS DESCRIBED. SEE INVESTIGATION DETAILS BELOW: INVESTIGATION (ORIGINAL GERRMAN LANGUAGE): AUSZUG AUS DEM LOGFILE: ANALYSE ZUM ANGEGEBEN ZEITPUNKT IM CER: (B)(6) 2021. (B)(6) 2021 11:50:01 GERäT VOM ANWENDER EINGESCHALTET. 12:00:08 STANDBY AKTIVIERT NACH KURZER SCMV BEATMUNG, GERäT BEFAND SEITDEM IM STANDBY MODE BIS UM (B)(6) 2021,14:52:03 DAS GERäT WIEDER VOM ANWENDER AUSGESCHALTET WURDE. IN DIESEN ZEITRAUM WURDE MEHRMALS AC GETRENNT UND WIEDER VERBUNDEN. FAZIT (19/JAN/22 3:03 PM): ALLE 3 ZEITPUNKTE ZEIGEN KEINEN TOTALAUSFALL DES BEATMUNGSGERäTES. GENERELL IST IN DEN LOG FILES KEIN TOTALAUSFALL ZU ERKENNEN. SOLLTE DAS GERäT WIRKLICH VON ALLEINE KOMPLETT ABGESCHALTET HABEN, WüRDE BEIM NäCHSTEN DIREKTEN AUFSTARTEN WENIGSTENS "ON VENTILATION SOFTWARE" HINTERLEGT WERDEN, VOM GERäT. DIES IST HIER IN DEN LOG FILES NICHT ZU ERKENNEN. DER EINTRAG "OFF VENTILATION SOFTWARE" WEIST DARAUFHIN, DASS DAS GERäT BEWUSST VOM ANWENDER AUSGESCHALTET WORDEN IST. DIREKT NACH DIESEN EINTRAG ERKENNT MAN DAS NäCHSTE ERFOLGREICHE AUFSTARTEN VOM GERäT ," ON VENTILATION SOFTWARE". ANHAND DER LOGFILES GAB ES KEINEN STOPP DER BEATMUNG ODER EIN TOTALAUSFALL DES GERäTES. INVESTIGATION (TRANSLATED WITH GOOGLE TRANSLATOR): EXCERPT FROM THE LOG FILE: ANALYSIS AT THE SPECIFIED TIME IN THE CER: (B)(6) 2021. (B)(6) 2021 11:50:01 DEVICE SWITCHED ON BY THE USER. 12:00:08 STANDBY ACTIVATED AFTER SHORT SCMV VENTILATION, DEVICE HAS BEEN IN STANDBY MODE SINCE THEN UNTIL (B)(6) 2021, 14:52:03 THE DEVICE WAS SWITCHED OFF AGAIN BY THE USER. DURING THIS PERIOD, AC WAS DISCONNECTED AND RECONNECTED SEVERAL TIMES. CONCLUSION (19/JAN/22 3:03 PM): ALL 3 TIME POINTS SHOW NO TOTAL FAILURE OF THE VENTILATOR. IN GENERAL, NO TOTAL FAILURE CAN BE SEEN IN THE LOG FILES. IF THE DEVICE REALLY SWITCHED OFF COMPLETELY BY ITSELF, THE NEXT TIME YOU START IT UP DIRECTLY, AT LEAST "ON VENTILATION SOFTWARE" WOULD BE STORED BY THE DEVICE. THIS CANNOT BE SEEN HERE IN THE LOG FILES. THE ENTRY "OFF VENTILATION SOFTWARE" INDICATES THAT THE DEVICE WAS DELIBERATELY SWITCHED OFF BY THE USER. IMMEDIATELY AFTER THIS ENTRY YOU CAN SEE THE NEXT SUCCESSFUL START-UP OF THE DEVICE, "ON VENTILATION SOFTWARE". BASED ON THE LOG FILES, THERE WAS NO STOPPAGE OF VENTILATION OR A TOTAL FAILURE OF THE DEVICE. HAMILTON MEDICAL AG REFERENCE NR: (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DOCTOR'S HOSPITAL (B)(6) SAID VENT WAS ON PATIENT AND NOT PLUGGED IN. AFTER A WHILE THE VENT TURNED OFF AND DID NOT WORK. PATIENT PASSED AWAY WITH NO INFORMATION IF DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287442 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death