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

Model Number NA:RPL600-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

The reporter was questioning whether invacare guarantees our lifts being used with another manufactures sling.The reporter stated the rpl600-1 patient lift was being used with an unknown drive medical sling.The user fell to the floor and the lift fell on top of the user.The user sustained a broken arm.The lift is used on multiple users in a facility.

Manufacturer Narrative

This incident is being reported in an abundance of caution due to the user sustaining a fractured arm.The invacare patient lift was being used with an unknown drive medical sling.Invacare only recommends the use of invacare accessories and slings with invacare lifts and has not tested other manufactures slings or accessories.The user fell from the sling/lift for an unknown reason and the lift fell on top of them resulting in a fracture to the arm.The reporter was still investigating this incident and was unable to provide any further detail.It is unclear what if any malfunction occurred causing the lift to fall over.Multiple attempts for further information were made without success.The manufacturing location for this particular device was unknown.However, the current manufacturing location for this device was invacare invamex.

• Brand Name: RELIANT 600 HD LOW BASE LIFT 9153640382
• Type of Device: 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: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 17317844
• MDR Text Key: 319097061
• Report Number: 9616091-2023-00016
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NA:RPL600-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1