MAUDE Adverse Event Report: HAMILTON MEDICAL AG FLOW SENSOR

Model Number	155500
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag case number is: (b)(4).
Event or Problem Description
The following was reported to hamiton medical ag: customer reports:- we've had an issues with the neo flow sensors used on our g5's in cicu over the weekend.A couple have split in the same position after a short period of time, which affected the vented patients.Affect on patient is unknown.No further information received so far.No patient harm or consequences.
Additional Manufacturer Narrative
Hamilton medical ag case number is: (b)(4).Follow-up 1 - corrected information: **udi related data quality updates only** field d4 was updated with full udi information.Updated fields: b4, d1, d2a, d2b, d4, d10, g4, g6, h2, h4, h5, h8, h11.
Event or Problem Description
The following was reported to hamiton medical ag: customer reports:- we've had an issues with the neo flow sensors used on our g5's in cicu over the weekend.A couple have split in the same position after a short period of time, which affected the vented patients.Affect on patient is unknown.No further information received so far.No patient harm or consequences.
Event or Problem Description
The following was reported to hamilton medical ag: customer reports: we've had an issues with the neo flow sensors used on our g5's in cicu over the weekend.A couple have split in the same position after a short period of time, which affected the vented patients.Affect on patient is unknown.No further information received so far.No patient harm or consequences.
Additional Manufacturer Narrative
Hamilton medical ag case number is: (b)(4).Follow-up 1 - corrected information: field d4 was updated with full udi information.A detailed investigation was performed by an expert from the technical service: during ventilation of a patient the flow sensor cracked.Subsequently, the flow sensor needed to be replaced.The cracks in the outer shell of the patient side housing of the neonatal flow sensor were caused by mechanical stress-cracking due to one of the connecting counterparts not being within the tolerances according to iso 5356-1.The hamilton neonatal flow sensor is manufactured according to iso 5356-1, but hamilton medical cannot guarantee that connected components are also hamilton medical products and comply with the iso standard.The device itself worked as intended.In consequence (correction) the affected flow sensors were replaced.No harm to patient, user or third party person was reported.The issue is not likely to be serious to public health but has potential to cause a delay in treatment or an intervention, if it were to recur during the use with a patient.Therefore, the event has been deemed to be a reportable event.

• Brand Name: FLOW SENSOR
• Common Device Name: FLOW SENSOR
• 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: christof mueller ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 19080543
• Report Number: 3001421318-2024-00885
• Device Sequence Number: 6271896
• Product Code: BYX
• UDI-Device Identifier: 17630002801369
• UDI-Public: (01)17630002801369(10)GHH048(11)200923(17)250923(240)155500
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2025

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: 155500
• Device Catalogue Number: 155500
• Device Lot Number: GHH048
• 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: 02/15/2024
• Supplement Date Received by Manufacturer: 02/15/2024; 02/15/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 11/26/2024; 03/19/2025
• Date Device Manufactured: 09/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FLOW SENSOR NEO SINGLE USE, PART NR 155500, GHH048; HAMILTON-G5 VENTILATOR; HAMILTON-G5 VENTILATOR
• Patient Sex: Unknown