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

Model Number HAMILTON-H900

Device Problems Insufficient Heating (1287); Moisture or Humidity Problem (2986)

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

Event Date 02/09/2023

Event Type  malfunction  

Manufacturer Narrative

Hamilton medical ag requested further information from the hospital regarding the number of the patient(s ) involved and the occurrence of incident.We haven`t received feedback yet.Technical fault 10 indicates a defective (short circuit) breathing circuit.Investigation is ongoing.

Event Description

Hamilton medical ag received the following incident description:"the tf 10 tube fuse error occurred during ventilation on six h900s in combination with the leoni plus.During the test, no fault could be found in the h900 ref of hose systems 260185".

Manufacturer Narrative

It was discovered that some of the reported events happened during the ventilation of a patient.Based on the customer's statement that during ventilation, tf10 had occurred at 6 different hamilton-h900, after replacement of the tube sets this error message disappeared on all 6 hamilton-h900.Tf 10 is called "tube fuse error" means the fuses of the heating for the breathing circuit are blown caused by a short cut between the wires inside the breathing circuit.Since we did not receive the effected breathing circuit sets, analysis could not be performed.According to our knowledge from past failure analyses, the possible cause that can lead to a tf 10 is a short circuit between pin 3 and pin 4.

Event Description

Hamilton medical ag received the following incident description:"the tf 10 tube fuse error occurred during ventilation on six h900s in combination with the leoni plus.During the test, no fault could be found in the h900 ref of hose systems (b)(4).".

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.With this investigation it has been confirmed that the device failed to meet its specifications at the time of the event while the humidifier was used on a patient (the humidifier was then not working).The root cause could not be determined but humidity in the device (due to the usage) may have had an impact.No correction needed to be performed when the device was checked.There was no reported patient or user harm.

Event Description

Hamilton medical ag received the following incident description:"the tf 10 tube fuse error occurred during ventilation on six h900s in combination with the leoni plus.During the test, no fault could be found in the h900 ref of hose systems 260185".

• Brand Name: HAMILTON-H900
• Type of Device: 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: 16434028
• MDR Text Key: 310286446
• Report Number: 3001421318-2023-00346
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,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: 02/24/2023
• Supplement Dates Manufacturer Received: 02/09/2023; 02/09/2023
• Supplement Dates FDA Received: 06/15/2023; 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