MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C2

Model Number	160002
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to hamilton medical ag: summary: unit doesn't start up.
Additional Manufacturer Narrative
Hamilton medical ag comes to the conclusion: investigation ongoing.
Event or Problem Description
The following was reported to hamilton medical ag: summary: unit doesn't start up.
Additional Manufacturer Narrative
Hamilton medical ag comes to the conclusion: the allegation in this complaint was confirmed to be a complaint as a malfunction of the device could be identified.With this investigation it has been confirmed that the device failed to meet its specifications at the time of the event.The investigation showed that after the device stopped ventilation, the operator intervened and the patient was ventilated using an ambu bag.This did not result in any patient harm.Further no user or third party harm was reported.Based on the information available, this issue may have caused or contributed to a death or a patient harm.Because a potential hazard could be present in this case, this event was classified as reportable.The hamilton medical service technician went to the customer to clarify the situation.The device involved was examined and it was found that the internal battery was defective or too old because the displayed battery charge level was not correct.The internal battery of the device involved was replaced to solve the issue.Further the device was checked successfully with the service software and released afterwards.Sidenote: the analysis found that the hamilton-c2 device involved in the event was being used in an ambulance vehicle when it stopped ventilation so it was not used in accordance with its intended purpose.A hamilton-c2 may only be used within a hospital for patient transport.No capa will be triggered.Nevertheless the failures are monitored constantly and if the failure rate was to increase a capa will be considered.
Event or Problem Description
The following was reported to hamilton medical ag: "the report from hospital say: 13:56 completed the self inspection of the transfer ventilator within the department and departed for the emergency department of hengli hospital in dongguan city to transfer a child with sudden cardiac and respiratory arrest.They arrived at the scene at around 14:45 and prepared for transfer after evaluating the patient.After turning on the power button of the transfer ventilator, the machine immediately triggered an alarm and displayed "self inspection failure, technical event".It could not be used.After shutting down and restarting twice, it reported the same error.After the third startup, it returned to normal and adjusted the parameters to connect the patient for transfer.The entire transfer process took about 20 minutes.The backup power supply for boarding showed at least 3 grids, which was expected to be sufficient to maintain the transfer.However, the ambulance returned to about 500 meters away from the hospital and suddenly shut down without any signs, and the machine could not be restarted.The patient was immediately resuscitated.Manually ventilate the bag to transfer to the ward.After dealing with the patient, the transport ventilator was able to restart after almost restarting.After unplugging the power, it was found that the machine still had 3 compartments of reserve power.".
Additional Manufacturer Narrative
A detailed investigation was performed by an expert from the technical service: the allegation in this complaint was confirmed to be a complaint as a malfunction of the device could be identified.With this investigation it has been confirmed that the device failed to meet its specifications at the time of the event.The investigation showed that after the device stopped ventilation, the operator intervened and the patient was ventilated using an ambu bag.This did not result in any patient harm.Further no user or third party harm was reported.Based on the information available, this issue may have caused or contributed to a death or a patient harm.Because a potential hazard could be present in this case, this event was classified as reportable.The hamilton medical service technician went to the customer to clarify the situation.The device involved was examined and it was found that the internal battery was defective or too old because the displayed battery charge level was not correct.The internal battery of the device involved was replaced to solve the issue.Further the device was checked successfully with the service software and released afterwards.Sidenote: the analysis found that the hamilton-c2 device involved in the event was being used in an ambulance vehicle when it stopped ventilation so it was not used in accordance with its intended purpose.A hamilton-c2 may only be used within a hospital for patient transport.No capa will be triggered.Nevertheless the failures are monitored constantly and if the failure rate was to increase a capa will be considered.
Additional Manufacturer Narrative
Hamilton medical ag comes to the conclusion: the allegation in this complaint was confirmed to be a complaint as a malfunction of the device could be identified.With this investigation it has been confirmed that the device failed to meet its specifications at the time of the event.The investigation showed that after the device stopped ventilation, the operator intervened and the patient was ventilated using an ambu bag.This did not result in any patient harm.Further no user or third party harm was reported.Based on the information available, this issue may have caused or contributed to a death or a patient harm.Because a potential hazard could be present in this case, this event was classified as reportable.The hamilton medical service technician went to the customer to clarify the situation.The device involved was examined and it was found that the internal battery was defective or too old because the displayed battery charge level was not correct.The internal battery of the device involved was replaced to solve the issue.Further the device was checked successfully with the service software and released afterwards.Sidenote: the analysis found that the hamilton-c2 device involved in the event was being used in an ambulance vehicle when it stopped ventilation so it was not used in accordance with its intended purpose.A hamilton-c2 may only be used within a hospital for patient transport.No capa will be triggered.Nevertheless the failures are monitored constantly and if the failure rate was to increase a capa will be considered.Hamilton medical ag complaint number: (b)(4).Follow-up 3 - corrected information: **udi related data quality updates only** field d4 was updated with full udi information.Updated fields: b4, d1, d2a, d4, g6, h2, h4, h5, h11.
Event or Problem Description
The following was reported to hamilton medical ag: summary: unit doesn't start up.

• Brand Name: HAMILTON-C2
• Common Device Name: HAMILTON-C2
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, switzerland 7402 ; SZ 7402
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz, switzerland 7402 ; SZ 7402
• MDR Report Key: 19535475
• Report Number: 3001421318-2024-01413
• Device Sequence Number: 12896772
• Product Code: CBK
• UDI-Device Identifier: 07630002800730
• UDI-Public: (01)07630002800730(21)11698(11)160721(240)160002
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/15/2024

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: 160002
• Device Catalogue Number: 160002
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: 06/05/2024; 07/09/2024; 07/09/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 07/12/2024; 07/18/2024; 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2016
• 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 Sex: Unknown