MAUDE Adverse Event Report: HAMILTON MEDICAL AG EXPIRATORY VALVE SET

Model Number	EXPIRATORY VALVE SET
Medical Device Problem Codes	Obstruction of Flow (2423); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Case under investigation.Hamilton medical ag reference number is cer (b)(4).
Event or Problem Description
The following was reported to hamilton medical ag: reusable expiratory valve (pn:160245) for hamilton-c6 after the reprocessing process, the membrane sticks to the valve body, which is not checked during the leak test.An occlusion alarm appears immediately when ventilation is started.No patient involvement.
Additional Manufacturer Narrative
A detailed investigation was performed by an expert from the technical service: no further investigation or correction will be performed except those mentioned above.In future hamilton medical ag will report an event similar to this issue as it will be deemed a reportable event.The allegation in this complaint was confirmed to be a complaint.With this investigation it has been confirmed that the device failed to meet its specifications at the time of the event while the ventilator was used.The root cause was determined to be a defect expiratory valve which was replaced.There was no patient or user harm.Hamilton medical ag reference number is cer (b)(4).
Event or Problem Description
The following was reported to hamilton medical ag: reusable expiratory valve pn:(b)(4) for hamilton-c6 after the reprocessing process, the membrane sticks to the valve body, which is not checked during the leak test.An occlusion alarm appears immediately when ventilation is started.No patient involvement.

• Brand Name: EXPIRATORY VALVE SET
• Common Device Name: EXPIRATORY VALVE SET
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: nikolai sonnenberg ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 16245917
• Report Number: 3001421318-2023-00038
• Device Sequence Number: 6351853
• Product Code: CBK
• UDI-Device Identifier: 07630002801133
• UDI-Public: (01)07630002801133
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

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
• Device Model Number: EXPIRATORY VALVE SET
• Device Catalogue Number: 160245
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown