MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON MEDICAL AG; HAMILTON-T1

Model Number HAMILTON-T1

Device Problem Gas Output Problem (1266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

Hamilton medical ag case number is cer (b)(4).The investigation is ongoing.

Event Description

The following was reported to hamilton medical ag: - this event was reported to hamilton medical ag as, ventilator device alarmed repeatedly in pcv+ mode following various medium and high priority alarms.- this occurrence was noticed during patient ventilation.- a continuous alarm was observable both visually (message alert and alarm codes) and through hearing.'low oxygen alarm' and the following patient alarms (pa).Pa141003 (vt low), pa141005 (low minute volume), pa133002 (inspiratory volume limitation) and pa141017 (disconnection on patient side).- the device log files (service log, error log, event log) were provided to hamilton.- there is patient involvement reported.This occurrence was noticed during patient ventilation but is not further specified nor explained.- there was need for medical intervention reported.Patient was ventilated by using a manual resuscitator (ambu bag) while staff tried to troubleshoot the low o2 issue.Subsequently the patient got connected to a replacement ventilator.- neither delay in treatment nor harm to the patient, user or third party has been reported.The investigation is ongoing.

• Brand Name: HAMILTON MEDICAL AG
• Type of Device: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, ; SZ
• 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: 18921092
• MDR Text Key: 337865518
• Report Number: 3001421318-2024-00642
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07630002813549
• UDI-Public: 07630002813549
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K181216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HAMILTON-T1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1