MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; RESUS,MAN,ADLT,BAG RES,PEEP,MANO,FILT

Model Number	CPRM4416FPM
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility, "code blue ed therapist was bagging patient heard a loud swishing noise patient o2 sat started dropping.Switched out bag and o2 sat starting rising".
Additional Manufacturer Narrative
According to the facility, "code blue ed therapist was bagging patient heard a loud swishing noise patient o2 sat started dropping.Switched out bag and o2 sat starting rising".The patient was transferred to a higher level of care hospital.The facility stated, "when the patient left the facility to be transferred the patient was ventilated".No additional details are available related to the customer reported issue.The sample was requested for evaluation.It has been determined that the reported event caused or contributed to (death/serious injury), therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Update to h6: type of investigation (b).Update to h6: investigation findings (c).Update to h6: investigation conclusions (d).

• Brand Name: MEDLINE
• Common Device Name: RESUS,MAN,ADLT,BAG RES,PEEP,MANO,FILT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: sabrina surmaj ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24513317
• Report Number: 1417592-2026-00179
• Device Sequence Number: 10297750
• Product Code: BTM
• UDI-Device Identifier: 10193489019049
• UDI-Public: 10193489019049
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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?: Yes
• Device Model Number: CPRM4416FPM
• Device Lot Number: 555593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2025
• 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; Life Threatening
• Patient Sex: Unknown