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

Model Number	3130001
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the motor was attached using the carriage s65 with single hook and a q link ii.It was reported that the strap was "loose on the roll", which allowed the multirall to fall.The motor has been requested to be returned to the manufacturer for inspection, a follow up report will be submitted upon completion of the investigation.
Event or Problem Description
A user report was received from the mpa stating that the multirall 200 lift had an issue.When mounting the lift up, the lift released the black ribbon.The lift fell onto the patient's bed.Fortunately, the patient was lying to the right and the lift ended up on the left side.This occurred during patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.There were no other devices reported to be involved.
Event or Problem Description
A user report was received from the mpa stating that the multirall 200 lift had an issue.When mounting the lift up, the lift released the black ribbon.The lift fell onto the patient's bed.Fortunately, the patient was lying to the right and the lift ended up on the left side.This occurred during patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.There were no other devices reported to be involved.
Additional Manufacturer Narrative
The lift was returned to lulea site for investigation.The investigation concluded that the lift had been operated without tension on the strap causing the strap to fold on the drum.The lift strap was then unfolded as it was lowered, causing the lift to fall.This issue is determined to be caused by user error.Multirall 200 overhead lift is a general-purpose lift with the intended use in: health care, intensive care and rehabilitation.Multirall 200 overhead lift is easy to move between facilities and useful for room-to-room transitions.Multirall 200 overhead lift can be mounted to the rail carriage in two different ways, mounted with the lift strap under the lift unit or mounted with the lift strap above the lift unit.Intended for use in all common lift and transfer situations, for example, between bed/wheelchair, to/ from floor, toilet visits, gait training, and for horizontal lifts with stretchers.Although there was no device malfunction found and the incident can be attributed to use error, if the reported incident were to recur, it could lead to serious injury or death.

• Brand Name: MULTIRALL
• 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: 21771404
• Report Number: 8030916-2025-00061
• Device Sequence Number: 18197837
• Product Code: FSA
• UDI-Device Identifier: 00887761982284
• UDI-Public: (01)00887761982284
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/22/2025
• 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