MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; ANESTHESIA CIRCUIT - LF

Catalog Number	DYNJAA11094A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Related to medwatch: (b)(4).According to the facility on (b)(6) 2024 the patient was brought back to the operating room for a scheduled surgery.Per the facility the "anesthesiologist could not get the ventilator to deliver the prescribed tidal volumes".Per the facility "after multiple checks on the ventilator and circuit connections, the circuit tubing was changed".Per the facility after the tubing was changed the prescribed volume was delivered to the patient.Per the facility the anesthesia setup was tested prior to patient use with no defect noted.Per the facility there was noted to be "a marked area with a metallic cord" when the device was received from the surgical director (after use).Per the facility the anesthesiologist "was able to bag the patient until a replacement was obtained".No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility on (b)(6) 2024 the patient was brought back to the operating room for a scheduled surgery.Per the facility the "anesthesiologist could not get the ventilator to deliver the prescribed tidal volumes".

• Common Device Name: ANESTHESIA CIRCUIT - LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 20608908
• Report Number: 1417592-2024-00942
• Device Sequence Number: 20869186
• Product Code: CAI
• UDI-Device Identifier: 40195327683673
• UDI-Public: 40195327683673
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJAA11094A
• Device Lot Number: 24DBJ023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 72 KG