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

Model Number	RPL450-1
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	03/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The scale is an optional accessory that is installed onto the lift between the boom and hanger bar.During transfer, the patient is placed into a sling, which is connected to the hanger bar.If the scale hardware detaches, the hanger bar will also be disconnected from the lift.If the patient is being supported within the sling when this occurs, it will likely result in the patient falling.There is no indication that a patient fall occurred during the reported event.The patient weighs approximately 160 pounds, which is below the lift's weight capacity of 450 pounds.The rpl450-1 user manual provides instructions for installation of the scale.It warns, "after any adjustments, repair or service and before use, make sure all attaching hardware is securely tightened; otherwise, injury or damage may occur." the maintenance safety inspection checklist within the manual provides a list of items that should be inspected/adjusted monthly, including all hardware and hanger bar supports on the boom.A product malfunction has not been confirmed.With the limited information available and without inspecting the lift, the cause of the failure is not definitive.However, the described failure is consistent with one that has been previously identified and investigated.It was determined that the root cause of the failure was an inadequate joint design at the hanger bar attachment point.Multiple contributing factors were also noted, including lack of torque specifications during manufacturing and conflicting information in user instructions.Corrective actions were implemented, including a redesign of the joint, updates to the work instructions to specify appropriate torque, updates to user instructions, and working with the scale supplier to redesign the mounting bracket.Note: the manufacturing location of the subject lift is unknown.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 nurse at a facility reported that while a patient was being transferred from a bed to a wheelchair using an rpl450-1 lift, the scale hardware kit separated from the main lift bar.The scale hardware kit fell on the patient's chest/lap.No injury was reported.The nurse elected to remain confidential, so no further information can be requested.

• 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: 19238295
• Report Number: 9616091-2024-00007
• Device Sequence Number: 12761647
• Product Code: FSA
• UDI-Device Identifier: 00841447102953
• UDI-Public: 00841447102953
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/03/2024

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
• Operator of Device: Health Professional
• Device Model Number: RPL450-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 82 YR
• Patient Sex: Female
• Patient Weight: 73 KG