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

Model Number	3130001
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The q-link component was requested to be returned for inspection but has not yet been received by baxter, therefore the reported malfunction could not be confirmed.According to baxters records, multirall with sn (b)(6) falls under the responsibility of a third-party distributor and the q-link was replaced to a q-link ii.Although there was no patient injury reported and the customers allegation could not be confirmed, if the q-link i were to be used in conjunction with a multirall overhead lift, it could lead to a serious injury or death, therefore baxter is reporting this alleged malfunction.Any additional relevant information received regarding this event will be submitted in a supplemental report.
Event or Problem Description
A customer contacted technical service to report that multirall 200 unit had a recall a few years prior and the customer was not informed by the 3rd party they bought the unit from nor had the corrective action parts been replaced.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• 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 975 9 2; SW 975 92
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20726157
• Report Number: 8030916-2024-00101
• Device Sequence Number: 8949392
• Product Code: FSA
• UDI-Device Identifier: 00887761982284
• UDI-Public: (01)00887761982284(11)190726
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/19/2024

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: Lay User/Patient
• Device Model Number: 3130001
• Device Catalogue Number: 3130001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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