MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; RESUSCITATOR,ADLT,MASK,TUB RES

Catalog Number	CPRM4426
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	09/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a resuscitation attempt involving an adult male patient, the medline resuscitation bag reportedly failed to adequately ventilate the patient.The patient experienced desaturation and did not improve while the medline device was in use.Upon switching to a previously stocked resuscitation bag from another brand, ventilation improved and the patient's oxygen saturation increased.The facility reported problems with adequate delivery of positive pressure when the bag is not held perfectly straight, as pressure is lost when torque is applied at the junction to the adapter.
Additional Manufacturer Narrative
During a resuscitation attempt involving an adult male patient, the medline resuscitation bag reportedly failed to adequately ventilate the patient.The patient experienced desaturation and did not improve while the medline device was in use.Upon switching to a previously stocked resuscitation bag from another brand, ventilation improved and the patient's oxygen saturation increased.The facility reported problems with adequate delivery of positive pressure when the bag is not held perfectly straight, as pressure is lost when torque is applied at the junction to the adapter.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: RESUSCITATOR,ADLT,MASK,TUB RES
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 23336402
• Report Number: 1417592-2025-00561
• Device Sequence Number: 9461275
• Product Code: BTM
• UDI-Device Identifier: 10888277700505
• UDI-Public: 10888277700505
• 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): 10/20/2025

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: CPRM4426
• Device Lot Number: 561911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2025
• 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
• Patient Sex: Male