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

Model Number HAMILTON-H900

Device Problem Temperature Problem (3022)

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

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

Hamilton medical ag case number is cer (b)(4).Investigation still ongoing.

Event Description

The following was reported to hamilton medical ag: a neonate got transported.The hamilton-h900 humidifier device overheated.Hot water vapor coming from the hamilton-h900 humidifier reaches the neonate through a high flow nasal cannula.No maintenance to the hamilton-h900 humidifier has been carried out since its first commissioning 27-feb-2020.This occurrence was noticed during patient ventilation.Whether the humidifier device alarmed was not reported.No device log files were provided to hamilton.There is patient involvement reported.Agitated baby (3 months, 6kg), tachycarda with increased oxygen requirements.There was need for medical intervention reported.The hamilton-h900 humidifier device got immediately disconnected and taken out of service.Neither delay in treatment nor harm to the patient, user or third party has been reported.The investigation is ongoing.

• 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: albert beckers ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 18235921
• MDR Text Key: 329316439
• Report Number: 3001421318-2023-04033
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/30/2023

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: 11/23/2023
• Initial Date FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1