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

Model Number HAMILTON-H900

Device Problem Moisture or Humidity Problem (2986)

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

Event Date 07/27/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

Hamilton medical ag received the following description: during ventilation, water from the h900 humidifier backed up into the inspiratory limb and into the endotracheal tube.The respiratory therapist intervened and suctioned the patient.Visual and acoustic alarms were triggered.

• Brand Name: HAMILTON-H900
• Type of Device: 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: konstantin deilhof ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 17582295
• MDR Text Key: 321518572
• Report Number: 3001421318-2023-02944
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/21/2023

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
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/21/2023
• 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