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

Catalog Number 950001

Device Problem Failure to Select Signal (1582)

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

Event Date 12/05/2023

Event Type  malfunction  

Event Description

Hamilton medical ag received the following event description: a hospital staff member noticed that while using the h900, the h900 had somehow changed to standby, even though no one had pressed the power button.He therefore replaced the h900 and asked the local staff to repair the h900.

Manufacturer Narrative

Investigation is ongoing.

• Brand Name: HAMILTON-H900
• Type of Device: HAMILTON-H900 HUMIDIFIER
• 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: 18435284
• MDR Text Key: 331784148
• Report Number: 3001421318-2024-00018
• 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: 505
• Type of Report: Initial
• Report Date: 01/03/2024

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 Catalogue Number: 950001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/03/2024
• 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