MAUDE Adverse Event Report: INVAMEX RELIANT 600 HD LOW BASE LIFT 9153640382; LIFT, PATIENT, AC-POWERED

Model Number	NA:RPL600-1
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident is being reported due to being likely to cause or contribute to a death or serious injury.There was no indication of patient involvement with this incident.The subject bolt secures the leg shifting mechanism to the base of the lift.If the bolt breaks or is missing, it prevents the legs from remaining in a locked position, which may result in instability.It is unclear if the missing bolt resulted from a device malfunction.The rpl600-1 user manual (part number 1078987-o) warns several times that the legs of the lift must be in the maximum open position and the shifter handle locked in place for optimum stability and safety.The manual also instructs: regular cleaning will reveal loose or worn parts, enhance smooth operation, and extend the life expectancy of the lift.
Event or Problem Description
Dealer stated the customer is requesting replacement hardware for the spreader bar on this rpl600-1 lift.He said the spreader bar fell off the other day and some of the hardware is now missing.He needs the bolts and springs for the spreader bar.

• Brand Name: RELIANT 600 HD LOW BASE LIFT 9153640382
• Common Device Name: LIFT, PATIENT, AC-POWERED
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: mike simmons ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 22967515
• Report Number: 9616091-2025-00014
• Device Sequence Number: 9109505
• Product Code: FNG
• UDI-Device Identifier: 00841447102977
• UDI-Public: 00841447102977
• Combination Product (Y/N): N
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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: Lay User/Patient
• Device Model Number: NA:RPL600-1
• 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: 08/08/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2025
• 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