MAUDE Adverse Event Report: INVAMEX RELIANT 600 HEAVY-DUTY POWER LIFT; NON-AC POWERED PATIENT LIFT

Model Number	RPL600-2
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Back pain (4895)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
While transferring the resident from wheelchair to bed using a patient lift, the spring or rod bent/broke causing the resident to drop to the bed and slide onto the floor.The patients fall resulted in back pain.No staff was injured.
Additional Manufacturer Narrative
This incident is being reported in an abundance of caution.The hospital contact provided the following details: there was no medical treatment required for the patient.They were not aware of the last time the lift was serviced and not aware of the actuator being previously replaced.The last time they used this lift was to weigh a patient and the lift functioned fine with no issues.The pictures of the lift confirmed the allegation of the actuator base and spring rod being broken.The hospital removed the lift from use.The cause of this issue has not been confirmed.It is unknown if the issue was due to lack of maintenance, use error, prior damage or a malfunction of the device.Should additional information become available, a supplemental record will be filed.The owner's manual for the rpl600-2 patient lift includes: detecting wear and damage: it is important to inspect all stressed parts for signs of cracking, fraying, deformation, or deterioration.Replace any defective parts immediately and ensure the lift is not used until repairs are made.The invacare patient lift is designed to provide a maximum of safe, efficient, and satisfactory service with minimum care and maintenance.All parts of the invacare lift are made of the best grades of steel, but metal-to-metal contact will cause wear after considerable use.

• Brand Name: RELIANT 600 HEAVY-DUTY POWER LIFT
• Common Device Name: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): INVAMEX; avenida el puente s/n; parque industrial el puente ma; reynosa, tamaulipas 88783 ; MX 88783
• Manufacturer (Section G): INVAMEX; avenida el puente s/n; parque industrial el puente ma; reynosa, tamaulipas 88783 ; MX 88783
• Manufacturer Contact: dona bhamra ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 25623568
• Report Number: 9616091-2026-00005
• Device Sequence Number: 13036829
• Product Code: FSA
• UDI-Device Identifier: 00841447102984
• UDI-Public: 00841447102984
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2026

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: Health Professional
• Device Model Number: RPL600-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• 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
• Patient Weight: 227 KG