MAUDE Adverse Event Report: INVAMEX RELIANT 450 BATTERY-POWERED LIFT; NON-AC POWERED PATIENT LIFT

Model Number	RPL450-1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Vertebral Fracture (4520)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This incident is being reported due to the patient lift actuator detaching from the boom attachment point resulting in the user falling and sustaining a serious injury.The patient was taken to the hospital.This device was 11 years old at the time of this issue.Multiple pictures were provided of the failure confirming the top of the actuator worn away over time.This is likely due to the bushing for the attachment hardware missing.The patient was 269 lbs, within the 450-pound weight capacity of the device.The facility was not aware of any mis-use of the lift at the time of the incident.The underlying cause of the actuator detachment resulting in the user falling is likely due to the device not being setup/assembled properly.This issue is being escalated internally for further review.This issue is believed to be similar to one that has been previously investigated and has been addressed through a corrective action.The root cause of this issue was found to occur during the initial setup of the device or replacement of the actuator.The provider or caregiver must mount the actuator to the boom/mast connection points.Due to several reasons, the user may omit the plastic bushing during assembly.Without the actuator bushing in-place, the rod eye will wear through from use overtime.Resolution for this issue has been implemented.This device was manufactured prior to the resolutions implemented in the corrective action.Should additional information become available, a supplemental record will be filed.
Event or Problem Description
On an rpl450-1 patient lift, the top of the actuator broke and dropped the patient, causing them to fall and break their neck.

• Brand Name: RELIANT 450 BATTERY-POWERED 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
• MDR Report Key: 24689642
• Report Number: 9616091-2026-00004
• Device Sequence Number: 21333159
• Product Code: FSA
• UDI-Device Identifier: 00841447102953
• UDI-Public: 00841447102953
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RPL450-1
• Device Catalogue Number: RPL450-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2015
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Female
• Patient Weight: 122 KG