MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MULTIRALL 200; LIFT PATIENT NON AC POWERED

Model Number	3130001
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested from the technician regarding the malfunction.A final report will be submitted upon completion of the investigation.
Event or Problem Description
Another health care professional contacted technical service to report that the multirall 200 engine could not be charged.Process step during which this occurred was unknown.There was no patient/user injury, medical intervention, symptom, or adverse event reported.It was unknown if any second device was also involved.The customer did not know if this event was already communicated to another baxter department or authority.
Additional Manufacturer Narrative
The baxter technician found the hand control was defective and the charger cable had exposed wires.The issue was resolved by replacing the hand control and the charger.The issue is determined to be caused by an electrical malfunction (hand control) and worn charger cable, which exposed the wires.Reports of damaged or frayed hand controllers / other low voltage components are not directly connected to the main power supply and are unlikely to cause or contribute to death or serious injury.Dc voltage is low and exposure will only result in a mild electric shock.Reports of damaged power cord / charging cable with exposed copper metal wires can result in electrical injury.
Event or Problem Description
A other health care professional contacted technical service to report that the multirall 200 engine could not be charged.Process step during which this occurred was unknown.There was no patient/user injury, medical intervention, symptom, or adverse event reported.It was unknown if any second device was also involved.The customer did not know if this event was already communicated to another baxter department or authority.

• Brand Name: MULTIRALL 200
• Common Device Name: LIFT PATIENT NON AC POWERED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): LIKO AB; nedre vagen 100; lulea 97592 ; SW 97592
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23180844
• Report Number: 8030916-2025-00120
• Device Sequence Number: 9182379
• Product Code: FSA
• UDI-Device Identifier: 00887761982284
• UDI-Public: (01)00887761982284
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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
• Device Model Number: 3130001
• Device Catalogue Number: 3130001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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