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

Catalog Number 950001

Device Problem Temperature Problem (3022)

Patient Problems Burn(s) (1757); Superficial (First Degree) Burn (2685)

Event Date 05/25/2023

Event Type  Injury  

Event Description

Hamilton medical ag received the following event description: hamilton medical ag received the following incident description: in combination with leoni plus sn (b)(6) scalding of the patient in the nasal area due to extremely hot condensed water and air via the mini-cpap inspiratory hose.Expiratory filter was used, which was already very wet, since the leoni alarmed with overpressure error messages.The drug salviathymol was administered via the nebulizer during the incident.

Manufacturer Narrative

Leoni plus sn (b)(6) medical was used with h900 during the incident.The log files of the leoni plus has been received.Further information and the device used has been requested from the hospital.Investigation is ongoing.

Manufacturer Narrative

Leoni plus sn 0217004hul60501425-löwenstein medical was used with h900 during the incident.The log files of the leoni plus has been received.Further information and the device used has been requested from the hospital.Investigation is ongoing.Update: hamilton medical ag received further information regarding the incident.The hospital reported that: -the nebulized medicine is called salbutamol with saline, salviathymol (which was originally reported) was a typo.-the humidifier alarmed frequently throughout the morning.It indicated that the ventilator was standing at a wrong angle and that the hoses are not correctly inserted in the humidifier (inspiration and expiration) -> frequently corrected and the situation improved.The alarm lasted at least 20 minutes.-the mother of the patient noticed that the hamilton-bc8010 breathing circuit set hose of the minicpap felt very hot.She, therefore, quickly removed the nasal cannula from the nostrils and pushed it to the nasal bridge, disconnecting it from the rest of the hose system.Hot water also ran out of the cpap.-no abnormalities were found intraorally and in the nostrils of the patient, but slight reddening and slight swelling of the skin on the nasal bridge.A hamilton-h900 does not store log files that can be analyzed.However, we received above mentioned user information that the hamilton-h900 alarmed during patient ventilation.Hamilton medical ag has received and analyzed the log files from the leonie plus, the ventilator involved.The ventilation started on 25.05.2023 at 04:15.Between 04:15 and 08:12 continuous "cpap high" alarms occurred.At 06:19 the settings were last changed before the incident.Between 08:22 and 09:00 the disconnection alarm was active & repeating "cpap low" alarms occurred.Between 09:00 and 09:07 continuous "overpressure in expiration tube" alarms occurred.At 09:07 the ventilation stopped because the operator switched off the ventilator.The hamilton-h900 and hamilton-bc8010 breathing circuit set involved in the incident were analyzed.The following tests were carried out: -optical check of all the components -functionality of the negative temperature coefficient (ntc) sensor measuring the patient end temperature -pin resistances of the hamilton-bc8010 tubes -hamilton-h900 connector resistance -functionality of the lightguide responsible for chamber recognition and water level alarms -operation of the hamilton-h900 with the leoni ventilator was performed with the settings reported by the hospital with the three following scenarios: >normal use >with hamilton-h900 tilted forward at 10° >with no water in the chamber none of these tests uncovered a malfunction of compliant hamilton-h900 and hamilton-bc8010 breathing circuit set which could lead to critically high temperature at the patient interface.The only conducted test which led to high temperature when operating the complaint hamilton-h900 with the hamilton-bc8010 and a leoni plus ventilator at the settings reported by the hospital was as follows: ventilating the patient with interchanged ventilator-tube connections and then switching the tube-ventilator connection back to the proper configuration without stopping ventilation.Furthermore, in a previous investigation of a similar complaint ref nr.Cer 107052/bfarm ref.Nr.33696/22 from the same hospital, critically high temperatures at the patient interface only occurred when switching the expiratory and inspiratory tubes.Therefore, the most probable root cause for this incident is that the breathing circuit sets were cross connected, i.E., the inspiratory tube was connected to the expiratory port of the ventilator and the expiratory tube was connected to the inspiratory port of the ventilator.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.Due to the earlier incidents cer 107052 and cer 109823 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 actual incident, 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.

Event Description

Hamilton medical ag received the following event description: hamilton medical ag received the following incident description: in combination with leoni plus sn 0217004hul60501425 scalding of the patient in the nasal area due to extremely hot condensed water and air via the mini-cpap inspiratory hose.Expiratory filter was used, which was already very wet, since the leoni alarmed with overpressure error messages.The drug salviathymol was administered via the nebulizer during the incident.

• Brand Name: HAMILTON-H900
• Type of Device: HAMILTON-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: ildem ustunkol ceylan ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 17123429
• MDR Text Key: 317114716
• Report Number: 3001421318-2023-02345
• 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: 505
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 950001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 05/26/2023
• Supplement Dates FDA Received: 09/04/2023
• 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
• Patient Outcome(s): Required Intervention; Other