MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5; HAMILTON-G5 VENTILATOR

Catalog Number 159001

Device Problem Gas Output Problem (1266)

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

Event Date 02/07/2024

Event Type  malfunction  

Event Description

Hamilton medical ag received the following incident description: the exhalation valve cannot be calibrated before using the ventilator.

Manufacturer Narrative

Investigation is ongoing.

• Brand Name: HAMILTON-G5
• Type of Device: HAMILTON-G5 VENTILATOR
• 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: ildem ustunkol ceylan ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 18939945
• MDR Text Key: 338124727
• Report Number: 3001421318-2024-00672
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07630002800013
• UDI-Public: 07630002800013
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K193228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 159001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2024
• 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