MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161006
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); No Flow (2991)
Health Effect - Clinical Codes	Respiratory Insufficiency (4462); Insufficient Information (4580)
Date of Event	07/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag case number is cer (b)(4).Investigation ongoing.
Event or Problem Description
The following was reported to hamilton medical ag: hamilton medical ag received the following incident description: the patient had a sports accident.Problem-free ventilation in the ambulance.The patient was then transferred to the rescue helicopter, where alarms were raised about insufficient oxygen supply and no volumes/flow could be measured.Only the pressure curve showed values.The patient's thorax was no longer rising.After restarting the hamilton-t1 ventilator the situation did not improve.There was need for medical intervention reported.The patient was ventilated by using a manual resuscitator (ambu bag).Thereafter the patient was further ventilated by using the ambulance's medumat ventilator device.Neither delay in treatment nor harm to third party has been reported.However, harm to the patient was reported.The patient's chest could no longer be lifted and there was no visible chest movement.The investigation is still ongoing.
Event or Problem Description
The following was reported to hamilton medical ag: - hamilton medical ag received the following incident description: the patient had a sports accident.Problem-free ventilation in the ambulance.The patient was then transferred to the rescue helicopter, where alarms were raised about insufficient oxygen supply and no volumes/flow could be measured.Only the pressure curve showed values.The patient's thorax was no longer rising.After restarting the hamilton-t1 ventilator the situation did not improve.The patient was ventilated by using an ambu-bag.Thereafter the patient was further ventilated by using a different ventilator device.- please note that there was no harm to the patient reported due to the use and malfunction of the device.The patient was further supported first through ventilation over an ambu-bag and then a different device was used.The transportation of the patient till the hospital was possible and the patient was supported with the alternative device.The investigation is still ongoing.
Additional Manufacturer Narrative
Hamilton medical ag case number is (b)(4).This follow up no 1 mdr report includes the following corrections: - the wording of b5 updated to clarify that there was no harm to the patient reported due to the use and malfunction of the device.- imdrf codes a and e updated.Investigation ongoing.
Additional Manufacturer Narrative
Hamilton medical ag case number is (b)(4).This follow up no 1 mdr report includes the following corrections: the wording of b5 updated to clarify that there was no harm to the patient reported due to the use and malfunction of the device.Imdrf codes a and e updated.Investigation ongoing.A detailed investigation was performed by an expert from the technical service: the investigation of this incident has confirmed that the device did not fail to meet its specifications at the time of the event while the ventilator hamilton-t1was in use.According to the event and service logfiles, there are no entries regarding technical faults or events, i.E.A malfunction of the device is not apparent for the date of the event.The event logfiles confirms the low oxygen alarm during the use.The device indicated to the user that the oxygen flow was too low.This alarm was not a malfunction alarm but an alarm for the user that the connection may not be properly done.A possible reason could have been an untight connection between ventilator and source this issue could not be reproduced when the device was checked and a clear root-cause cannot be determined.The device was found working properly, no connection problem was observed.The device passed all tests during the checking after this event.However, this situation could have led to a deterioration of the patient's health which is why this case is assessed reportable (nevertheless no harm to the patient was reported).
Event or Problem Description
The following was reported to hamilton medical ag: hamilton medical ag received the following incident description: the patient had a sports accident.Problem-free ventilation in the ambulance.The patient was then transferred to the rescue helicopter, where alarms were raised about insufficient oxygen supply and no volumes/flow could be measured.Only the pressure curve showed values.The patient's thorax was no longer rising.After restarting the hamilton-t1 ventilator the situation did not improve.The patient was ventilated by using an ambu-bag.Thereafter the patient was further ventilated by using a different ventilator device.Please note that there was no harm to the patient reported due to the use and malfunction of the device.The patient was further supported first through ventilation over an ambu-bag and then a different device was used.The transportation of the patient till the hospital was possible and the patient was supported with the alternative device.The investigation is still ongoing.
Additional Manufacturer Narrative
Hamilton medical ag case number is (b)(4).This follow up no 1 mdr report includes the following corrections: the wording of b5 updated to clarify that there was no harm to the patient reported due to the use and malfunction of the device.Imdrf codes a and e updated.Investigation ongoing.A detailed investigation was performed by an expert from the technical service: the investigation of this incident has confirmed that the device did not fail to meet its specifications at the time of the event while the ventilator hamilton-t1was in use.According to the event and service logfiles , there are no entries regarding technical faults or events, i.E.A malfunction of the device is not apparent for the date of the event.The event logfiles confirms the low oxygen alarm during the use.The device indicated to the user that the oxygen flow was too low.This alarm was not a malfunction alarm but an alarm for the user that the connection may not be properly done.A possible reason could have been an untight connection between ventilator and source this issue could not be reproduced when the device was checked and a clear root-cause cannot be determined.The device was found working properly, no connection problem was observed.The device passed all tests during the checking after this event.However, this situation could have led to a deterioration of the patient's health which is why this case is assessed reportable (nevertheless no harm to the patient was reported).Hamilton medical ag complaint number: (b)(4).Follow-up 3 - corrected information: **udi related data quality updates only** a udi-di was provided for this device brand and version (generally) in the initial report, yet hamilton medical ag (hmag) established that this particular device (serial number: (b)(6)) was not labelled with a udi at the time of its manufacturing.Creation of udi was not a requirement at the time of manufacturing of this particular device (prior to 2015) and had not yet been implemented in production at hmag.Udi data has therefore been removed in this corrected follow-up report.A full udi (including udi-pi) will not be provided, this is in alignment with the information on the label on the device with the serial number (b)(6).Updated fields: b4, d4, g6, h2, h11.
Event or Problem Description
The following was reported to hamilton medical ag: hamilton medical ag received the following incident description: the patient had a sports accident.Problem-free ventilation in the ambulance.The patient was then transferred to the rescue helicopter, where alarms were raised about insufficient oxygen supply and no volumes/flow could be measured.Only the pressure curve showed values.The patient's thorax was no longer rising.After restarting the hamilton-t1 ventilator the situation did not improve.The patient was ventilated by using an ambu-bag.Thereafter the patient was further ventilated by using a different ventilator device.Please note that there was no harm to the patient reported due to the use and malfunction of the device.The patient was further supported first through ventilation over an ambu-bag and then a different device was used.The transportation of the patient till the hospital was possible and the patient was supported with the alternative device.The investigation is still ongoing.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: albert beckers ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 19749348
• Report Number: 3001421318-2024-01717
• Device Sequence Number: 20461330
• Product Code: CBK
• UDI-Device Identifier: 07630002813549
• UDI-Public: 07630002813549
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 161006
• Device Catalogue Number: 161006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 07/10/2024; 07/10/2024; 07/10/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 07/22/2024; 10/24/2024; 11/26/2024
• Date Device Manufactured: 09/08/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Male