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

Model Number HAMILTON-H900

Device Problems Device Alarm System (1012); Temperature Problem (3022)

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

Event Date 02/06/2023

Event Type  malfunction  

Event Description

Hamilton medical ag received the following event description: "the hospital staff claimed that the temperature high alarm did not go away when the h900 was being used on the patient, that replacing the breathing circuit set did not resolve the problem, and that the h900 was therefore replaced.".

Manufacturer Narrative

The breathing circuit set was destroyed by the hospital staff.Hmag requsted further information, investigation is ongoing.

Event Description

Hamilton medical ag received the following event description: "the hospital staff claimed that the temperature high alarm did not go away when the h900 was being used on the patient, that replacing the breathing circuit set did not resolve the problem, and that the h900 was therefore replaced.".

Manufacturer Narrative

A detailed investigation was performed by an expert from the technical service: no further investigation or correction will be performed except those mentioned above.In future hamilton medical ag will report an event similar to this issue as it will be deemed a reportable event.The allegation in this complaint was confirmed to be a complaint.The root cause could not be established.In consequence the device (humidifier) was replaced.There was no reported patient or user harm.

• Brand Name: HAMILTON-H900
• Type of Device: HAMILTON-H900 HUMIDIFIER
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: andre sonnenberg ; via crusch 1; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 16377328
• MDR Text Key: 309601494
• Report Number: 3001421318-2023-00204
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HAMILTON-H900
• Device Catalogue Number: 950001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 02/09/2023
• Supplement Dates FDA Received: 04/10/2024
• 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