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

Model Number HAMILTON-H900

Device Problems Device Displays Incorrect Message (2591); Intermittent Energy Output (4025)

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

Event Date 01/10/2022

Event Type  malfunction  

Manufacturer Narrative

The complaint has been reopened and reviewed according to fda form 483 inspectional observation ems #2, eobs2 from the fda inspection conducted between july 17 to july 21, 2022 at the ems and bonaduz sites.A detailed investigation was performed by an expert from the technical service:since the complaint in question was submitted to hamilton medical ag almost 2 years ago, no attempts will be performed to obtain additional information.No further investigation or correction will be performed except those mentioned above.In the 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 it was tested.The root cause(s) identified were a failure in the ntc temperature sensor, control board and/or other hardware component that caused variations in water temperature regulation, in conjunction with an erratic display of temperature values due to problems traced to a flaw in the software that caused it to produce an incorrect or unexpected result.There was no patient or user harm.The identified root cause was confirmed.

Event Description

I have got an h900 humidifier for rep, which is somewhat periodically unstable - sometimes it can run normally for hours, and other times the hotplate runs very slowly, and sometimes there is an expection - which i have been lucky to get a picture of - see attached, here after restarting the device, and report a completely different water temp.Than before the restart.

• Brand Name: HAMILTON MEDICAL AG
• Type of Device: HAMILTON-H900
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: andre sonnenberg ; via crusch 8; bonaduz, graubunden 7402 ; SZ 7402
• MDR Report Key: 17874634
• MDR Text Key: 324968574
• Report Number: 3001421318-2023-17851
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00730002856789
• UDI-Public: 0730002856789
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• 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: 950004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2022
• 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