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

Model Number HAMILTON-H900

Device Problem Failure to Read Input Signal (1581)

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

Event Date 07/26/2023

Event Type  malfunction  

Event Description

Hamilton medical ag received the following description: the h900 humidifier did not recognize the attached reusable circuit.The incident did not occur during patient ventilation.

Manufacturer Narrative

Investigation is ongoing.

Event Description

Hamilton medical ag no longer considers the case reportable for the following reason: initially, a lack of alarms had been communicated regarding this incident.This information turned out to be incorrect.With the presence of alarms, expected exposure time to the defective humidifier is considerably shorter.Short exposure time to the defective humidifier does not lead to serious injuries while longer exposure time could (under certain unfavourable circumstances).

• 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: 17602577
• MDR Text Key: 321726926
• Report Number: 3001421318-2023-02997
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: PE
• 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,Followup
• Report Date: 08/25/2023

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: 08/08/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 08/25/2023
• 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