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

Model Number	RPL450-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject bolt/screw secures the leg shifting mechanism to the base of the lift.If the bolt breaks, it prevents the legs from remaining in a locked position, which may result in instability.The rpl450-1 user manual 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.After the first six months of operation, inspect all pivot points and fasteners for wear.If the metal is worn, the parts must be replaced.Repeat this inspection every six months.The underlying cause of the alleged issue is unconfirmed.It is unclear if it resulted from wear, lack of maintenance, or a device malfunction.Note: since the lift's serial number is not available, its manufacturing date and location cannot be determined.The current manufacturer is invamex, so their cfn number is being used for the mdr filing.Should additional information become available, a supplemental record will be filed.
Event or Problem Description
A facility advised that they had an rpl450-1 lift that needed to be evaluated for repair.A technician went to the facility and found that the leg shift bolt between the base legs had sheared off.The technician removed the broken bolt, installed a new bolt, and realigned the legs.

• Brand Name: INVACARE RELIANT 450 BATTERY-POWERED LIFT
• Common Device Name: LIFT, PATIENT, NON-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: 19820125
• Report Number: 9616091-2024-00013
• Device Sequence Number: 8728174
• Product Code: FSA
• UDI-Device Identifier: 00841447102953
• UDI-Public: 00841447102953
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2024

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: RPL450-1
• 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: 05/06/2024
• Initial Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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