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 01/24/2024

Event Type  malfunction  

Event Description

The following has been reported to hamilton medical ag on (b)(6) 2024 it was reported that on (b)(6) 2024, customer complained of low oxygen alarm.Biomed was unable to duplicate concern.He went into ssw and ran o2 cell calibtations as well as o2 input, nebulizer, and o2 system tab tests.Everytime the staff gets the vent back they keep seeing low oxygen/ o2 failures.Patient was switched to another ventilatore impacted device is the hamilton t1 (sn (b)(6).According to the reporter, the biomed says that after esm board replacement, the device no longer has the proper product number to be selected under the modify tab.The technical state cannot be properly updated.Biomed cannot download any log files from the device.He says the current software vision is 2.2.5.According to the preliminary analysis, the root cause of this issue could be related to the following: temp.Influence (warm /cold state of the unit on the last calibration) oxygen sensor reached end of lifetime.Leak between the internal flowsensors qo2 and qvent.Accurate mixer qvent flowsensor out of tolerance.Leaking blower module.As per avaialble information there is no indication that the complaint lead to death, injury or serious deterioration of the health of the patient, user or third-party.

• Brand Name: HAMILTON MEDICAL AG
• Type of Device: 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, 7404 ; SZ 7404
• Manufacturer Contact: joseph barsey ; via cruch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 18903147
• MDR Text Key: 337651697
• Report Number: 3001421318-2024-00604
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07630002801850
• UDI-Public: 07630002801850
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2018
• 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