MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161006
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to hamilton medical ag: the patient was brought into the hospital because he/she was suffering from an out of hospital cardiac arrest.The patient was stable and needed to be transported to the ct.During preparation or before starting transport, the hamilton-t1 ventilator did not provided the set tidalvolume of 480 ml and the tidalvolume dropped to 130 ml which resulted in an spo2 drop to 80%.Hcp was at the bedside and immediately started ventilating the patient by using a manual resuscitator (ambu bag).The spo2 recovered to 100%.The spo2-drop was too short to cause any harm.Therefore, the hospital did not report any patient harm.Finally, another mechanical ventilator device got connected to the patient and the scheduled computed tomography (ct) treatment continued.Only the device event-log was provided.Hamilton medical ag did not receive the service-log and the error-log.Whether alarms were triggered was not reported to hamilton medical ag.The investigation is still ongoing.
Additional Manufacturer Narrative
Hamilton medical ag case number is cer (b)(4).Investigation ongoing.
Additional Manufacturer Narrative
Hamilton medical ag case number is (b)(4).Investigation ongoing.Hamilton medical ag complaint number: (b)(4).Follow-up 1 - corrected information: udi related data quality updates only.Field d4 was updated with full udi information.
Event or Problem Description
The following was reported to hamilton medical ag: the patient was brought into the hospital because he/she was suffering from an out of hospital cardiac arrest.The patient was stable and needed to be transported to the ct.During preparation or before starting transport, the hamilton-t1 ventilator did not provided the set tidal volume of 480 ml and the tidal volume dropped to 130 ml which resulted in an spo2 drop to 80%.Hcp was at the bedside and immediately started ventilating the patient by using a manual resuscitator (ambu bag).The spo2 recovered to 100%.The spo2-drop was too short to cause any harm.Therefore, the hospital did not report any patient harm.Finally, another mechanical ventilator device got connected to the patient and the scheduled computed tomography (ct) treatment continued.Only the device event-log was provided.Hamilton medical ag did not receive the service-log and the error-log.Whether alarms were triggered was not reported to hamilton medical ag.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: 19211219
• Report Number: 3001421318-2024-01052
• Device Sequence Number: 8193989
• Product Code: CBK
• UDI-Device Identifier: 07630002813549
• UDI-Public: 07630002813549
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 10/18/2024

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: 04/17/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 10/18/2024
• Date Device Manufactured: 03/30/2016
• 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