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

Model Number HAMILTON-T1

Device Problem Failure to Power Up (1476)

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

Event Date 01/25/2024

Event Type  malfunction  

Event Description

The following was reported to hamilton medical ag: during pm testing, customer was testing the vent and getting low oxygen readings during the system tab o2 mixer assembly test.All tests passed for the customer except for the low o2 readings during this test.No patient involvement.

Manufacturer Narrative

Hamilton medical ag case number is: (b)(4).

• 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, 7402 ; SZ 7402
• Manufacturer Contact: christof mueller ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 18711764
• MDR Text Key: 335474639
• Report Number: 3001421318-2024-00376
• Device Sequence Number: 1
• Product Code: CBK
• 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: User Facility,Distributor
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HAMILTON-T1
• Device Catalogue Number: 161009
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2024
• 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