MAUDE Adverse Event Report: HAMILTON MEDICAL AG FLOW SENSOR; FLOW SENSOR FOR ALL HAMILTON VENTILATORS, PEDIATRIC/ADULT, 188CM, SINGLE-USE

Model Number	281637
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to hamilton medical ag: a break in the transparent line of the flow sensor.This abnormity was noticed in the preparation stage, before usage.There is no patient involvement reported.There was no need for any medical intervention reported.Neither delay in treatment nor harm to the patient, user or third party has been reported.The investigation is still ongoing.
Additional Manufacturer Narrative
Hamilton medical ag case number is (b)(4).Investigation still ongoing.
Additional Manufacturer Narrative
A detailed investigation was performed by an expert from the technical service: the allegation in this complaint was confirmed to be a complaint as the pressure line of the flow sensor was broken.While unpacking to install the new flow sensor for patient use the product failure was noticed, which is considered a manufacturing deficiency (out of the box failure).In consequence (correction) the flow sensor was replaced.This new out of box product is classified with severity of s5 and no similar malfunction (deforming tubes) caused or contributed to any dsi within the past 2 years.Therefore, this event is assessed as non reportable.There is no patient involvement reported.The incident happened in the preoperational phase, during the setup of the patient circuit.There was no need for any medical intervention reported.Neither delay in treatment nor harm to the patient, user or third party has been reported.Currently there is no capa on this issue available because this is a single case based on the observation period.Nevertheless the failures are monitored constantly and if the failure rate was to increase a capa will be considered.
Event or Problem Description
The following was reported to hamilton medical ag: a break in the transparent line of the flow sensor.This abnormity was noticed in the preparation stage, before usage.There is no patient involvement reported.There was no need for any medical intervention reported.Neither delay in treatment nor harm to the patient, user or third party has been reported.The investigation is still ongoing.

• Brand Name: FLOW SENSOR
• Common Device Name: FLOW SENSOR FOR ALL HAMILTON VENTILATORS, PEDIATRIC/ADULT, 188CM, SINGLE-USE
• 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: 18017709
• Report Number: 3001421318-2023-03671
• Device Sequence Number: 6586175
• Product Code: CBK
• UDI-Device Identifier: 07630002800860
• UDI-Public: 07630002800860
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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
• Operator of Device: Health Professional
• Device Model Number: 281637
• Device Lot Number: 201079801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown