MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-H900; H900 HUMIDIFIER

Catalog Number 950001

Device Problem Insufficient Information (3190)

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

Event Date 11/08/2022

Event Type  malfunction  

Manufacturer Narrative

Water leakage occurred from the water supply tube.The local staff received the breathing circuit set from the hospital staff and checked it, but did not reproduce the phenomenon.Investigation is ongoing.

Event Description

Hamilton medical ag received the following event description: "the hospital staff replaced the breathing circuit set after the chamber developed a leak.However, he had no choice but to replace the breathing circuit set again because the h900 had frequent low water alarms.".

• Brand Name: HAMILTON-H900
• Type of Device: H900 HUMIDIFIER
• Manufacturer (Section D): 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: 16409152
• MDR Text Key: 310188285
• Report Number: 3001421318-2023-00273
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K163283
• 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: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 950001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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