MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; HME, ADULT, COMPACT, STRAIGHT

Catalog Number	DYNJAAHME12
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the report received "the patients ventilator started to alarm so the patient was removed from the vent and attempts were made to provide ventilation with an ambu-bag.".
Additional Manufacturer Narrative
According to the report received "the patients ventilator started to alarm so the patient was removed from the vent and attempts were made to provide ventilation with an ambu-bag".Per the report "the heat and moisture exchanger (hme) was removed from the vent circuit and hooked to the expiratory filter outlet on the ambu-bag, the other end of the hme was hooked to the ett, the expiratory port on the ambu-bag was left open and the patient did not receive the intended breaths as a result".The facility contact information was not provided and therefore the sample cannot be evaluated.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.Please note this medwatch is in correlation with mw5164225.

• Common Device Name: HME, ADULT, COMPACT, STRAIGHT
• 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: 21422001
• Report Number: 1417592-2025-00098
• Device Sequence Number: 12703714
• Product Code: CAH
• UDI-Device Identifier: 10884389120453
• UDI-Public: 10884389120453
• Combination Product (Y/N): N
• 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): 02/20/2025

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: DYNJAAHME12
• Device Lot Number: 40020080063
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Age: 55 YR
• Patient Sex: Female