MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION THE METANEB SYSTEM; DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Model Number	C20000N
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) notified the distributor (b)(6) which was further reported to baxter on (b)(6) 2025.As per information provided based on new sample pictures, the filter was cracked, specifically one of the filter¿s barbs was cracked.There were no patient involvement and no injury or any impact on the patient or user resulting from this.
Additional Manufacturer Narrative
The baxter technician found the metaneb circuit assembly needed to be replaced.The metaneb® system is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen.A search of the baxter maintenance records did not show baxter performed any preventative maintenance on this product.It is unknown if the customer performs preventative maintenance on their products.A replacement metaneb circuit assembly was sent to the customer.Based on this information, no further actions are required at this time.Although there was no reported injury with this event, if the report of a broken filter were to recur, it could potentially cause serious injury or death.Therefore, baxter is reporting this event.

• Brand Name: THE METANEB SYSTEM
• Common Device Name: DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM SINGAPORE; 1 yishun avenue 7; singapore, north east 76892 3; SN 768923
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 24048060
• Report Number: 3008145987-2026-00004
• Device Sequence Number: 9494383
• Product Code: NHJ
• UDI-Device Identifier: 00887761997134
• UDI-Public: (01)00887761997134
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K124032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2026

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
• Operator of Device: Other
• Device Model Number: C20000N
• Device Catalogue Number: C20000N
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown