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

Catalog Number 950001

Device Problem Temperature Problem (3022)

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

Event Date 03/14/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

Hamilton medical ag received the following incident description: "the device heats up to 41°c at a setting of 37°c.".

Manufacturer Narrative

Hamilton medical ag received further information from the hospital and from our partner technician regarding the incident: according to the hospital, the device was set for noninvasive ventilation.A failure message occurred on the hamilton-h900, and limbs were hot.Failure was detected prior to use; patient was not connected to the device during the incident.The ventilator and humidifier were replaced.According to the partner, the hamilton-h900 was operated together with a leoni plus ventilator.The inspiratory limb from the hamilton-h900 was connected to the expiratory port on the leoni plus and the expiratory limb from the hamilton-h900 was connected to the inspiratory port on the leoni plus.Device alarmed with "high temperature".During the incident, the patient was not connected to the device, but on the mother's arm.Hamilton medical ag received the log files of the leoni plus ventilator, the actual hamilton-h900 and the breathing circuit used.A first check showed that the hamilton-h900 can be turned on and all buttons function normally.The device correctly recognizes limbs and water chamber, as well as water level inside.Heating plate and limb heating work correctly- no abnormal behavior nor alarm was observed.The breathing circuit was still connected upon arrival.Delivered parts show that the expiratory valve is connected to the short tube, while the inspiratory filter is connected to the expiratory limb suggesting that the connections between leoni plus and hamilton-h900 were mixed up at hospital side during the therapy.The hamilton-h900 and hamilton-bc8010 breathing circuit set involved in the incident were analyzed.The following tests were conducted: · resistance of the connector pins on the hamilton-h900.· functionality of the negative temperature coefficient (ntc) sensor measuring the patient end temperature · functionality of the lightguides, which detect water level high and low · resistance of the pins on the limbs of the breathing circuit set · software-hardware end-line tests of the hamilton-h900 · operation with ventilator in inv mode (correct limb connection).None of the tests performed could explain the high temperature.We were unable to reach temperatures high enough to reproduce the issue.The only test, which led to high temperature (not exceeding 41c) at the patient interface, was as follows: · operation with ventilator in inv mode (switched limbs): a state similar to the one described in the complaint could only be provoked by switching the expiratory and inspiratory limb connection at the ventilator and then reconnecting the limbs correctly after a while.It is to be noted hamilton medical ag received 2 similar incidents from the same hospital.According to the previous analysis of these similar incidents cer (b)(4) (bfarm 33696/22) and cer (b)(4) (bfarm 15473/23), high temperatures at the patient interface only occurred when switching the expiratory and inspiratory limbs and reconnecting the limbs correctly after a while.Due to the actual incident and an earlier incident cer (b)(4) from the same hospital, a training regarding usage/application of the breathing circuit sets and hamilton-h900 was conducted at the heilbronn hospital on 11.04.2023 and 17.04.2023.After the third incident cer (b)(4) at the same hospital, another visit to the hospital was performed by the product manager and the clinical application specialist on 22.06.2023.The correct application of the hamilton-h900 and the breathing circuit sets was re-emphasized.Please note that the hamilton-h900 ifu states: 1.4 general operation and setup warning · before using the humidifier on the patient, verify that the breathing circuit is correctly connected to the ventilator as follows: - the blue inspiratory limb is connected to the to patient inspiratory port.- the white expiratory limb is connected to the from patient expiratory port.1.5 breathing circuits and water chamber warning · failure to correctly connect the breathing circuit to the ventilator can injure the patient.In addition, to alert the user of mistaken limb connection, the hamilton-h900 features a flow direction detection which alarms if there is no flow in the chamber or if the air is flowing through the chamber in the incorrect direction.(i.E., the inspiratory and expiratory limb connections on the ventilator are switched) this alarm was triggered in tests conducted with the returned hamilton-h900 and the returned breathing circuit set, proving the alarm on the device functions as intended.Here it should be noted that the hospital personnel reported that an alarm, which they did not recognize, was triggered ahead of the incident.Hospital personnel mentioned an attached photo of the unknown alarm.Unfortunately, hamilton medical ag did not receive this photo even upon renewed inquiry.It is plausible that the unknown alarm, which was triggered, was the flow detection alarm.

Event Description

Hamilton medical ag received the following incident description:"the device heats up to 41°c at a setting of 37°c.".

• Brand Name: HAMILTON-H900
• Type of Device: H900 HUMIDIFIER
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: ildem ustunkol ceylan ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 16653819
• MDR Text Key: 312532028
• Report Number: 3001421318-2023-01117
• 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
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

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 Catalogue Number: 950001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 03/15/2023
• Supplement Dates FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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