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

Model Number	155500
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to hamilton medical ag: - hamilton medical ag received the following incident description: "hospital staff was assembling a breathing circuit set for use on a patient.When he took a new flow sensor out of the box, he noticed that the flow sensor had a crack." - there is no patient involvement reported.- there is 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 ongoing.
Additional Manufacturer Narrative
Hamilton medical ag case number is cer(b)(4).Investigation is ongoing.

• Brand Name: FLOW SENSOR
• Common Device Name: FLOW SENSOR FOR USE WITH ALL HAMILTON VENTILATORS, 188 CM, NEONATAL, 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 crush 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 20134687
• Report Number: 3001421318-2024-02035
• Device Sequence Number: 15291341
• Product Code: BYX
• UDI-Device Identifier: 07630002801362
• UDI-Public: (01)07630002801362(10)GHI050(11)210621(17)260621(240)155500
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXCEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2024

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: 155500
• Device Catalogue Number: 155500
• Device Lot Number: GHI050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 09/04/2024
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown