MAUDE Adverse Event Report: INVAMEX MANUFACTURING RELIANT 450 POWER LOW BASE LIFT 9153646735; NON-AC POWERED PATIENT LIFT

Model Number	NA:RPL450-2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Facility reported that the bolt connecting the hanger bar to the boom detached for an rpl450-2 patient lift.There was no harm to the patient.This issue is consistent with a previously investigated issue where it was discovered that the bolt can backout if the hanger bar swings back & forth with weight.The root cause of the bolt backing out was determined to be related to conflicting instructions in the manual and the unspecified torque specification of the bolt.The connection joint was redesigned to reduce friction, the lift scale connection point was redesigned, a torque specification was documented, and the user instructions were updated to clarify maintenance and replacement instructions.This device was manufactured by invacare suzhou in september 2015, prior to the design changes.Suzhou is no longer an active manufacturing site and invamex will be used as the manufacturing location for filing purposes.The lift is past its end of life of 8 years.
Event or Problem Description
While lifting a patient from the bed, the hanger bar on the rpl450-2 patient lift detached from the boom.In the process the bracket became bent, and the hanger bar fell onto the chest of the patient.The patient fell onto the bed.No injuries were reported or medical attention needed.This lift is used by multiple patients.

• Brand Name: RELIANT 450 POWER LOW BASE LIFT 9153646735
• Common Device Name: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): INVAMEX MANUFACTURING; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX MANUFACTURING; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: michael simmons ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 22440051
• Report Number: 9616091-2025-00010
• Device Sequence Number: 4745790
• Product Code: FSA
• UDI-Device Identifier: 00841447102960
• UDI-Public: 00841447102960
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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
• Operator of Device: Health Professional
• Device Model Number: NA:RPL450-2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2015
• 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