MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MONARCH SYSTEM; PERCUSSOR, POWERED-ELECTRIC

Model Number	PMACS1NA
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technical support found the power cord needed to be replaced.The monarch® system features eight pulmonary oscillating discs (pods) containing magnets, that are anatomically placed over the upper and lower lobes of the lungs.The pods oscillate and provide a targeted kinetic energy to the lungs.Airflow is generated to help thin and move mucus from the small airways to the large airways, where it can be coughed out or suctioned.A replacement power cord 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 damaged power cord with exposed copper wires were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.
Event or Problem Description
On 22-jan-2026, a patient contacted technical service to report that monarch model 1000 acs - basic (product code pmacs1na, serial number (b)(6)), had power cord damaged with copper wire exposed.This occurred at home during patient use.There was no patient injury or death reported with this event.

• Brand Name: MONARCH SYSTEM
• Common Device Name: PERCUSSOR, POWERED-ELECTRIC
• 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 ; 2242705355
• MDR Report Key: 24383832
• Report Number: 3008145987-2026-00014
• Device Sequence Number: 10622142
• Product Code: BYI
• UDI-Device Identifier: 00887761977495
• UDI-Public: (01)00887761977495(11)170917
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K163378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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: PMACS1NA
• Device Catalogue Number: PMACS1NA
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2017
• 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