MAUDE Adverse Event Report: INVAMEX RELIANT 450 POWER LOW BASE LIFT 9153646735; LIFT, PATIENT, AC-POWERED

Model Number NA:RPL450-2

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 particular incident.The reporter provided pictures that appeared to confirm the bushing was missing from the actuator boom connection point.This issue has been addressed through a corrective action.The root cause of this issue was found to occur during the initial setup of this device.The provider or caregiver must mount the actuator to the boom connection.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 until it no longer supports the boom.Resolution for this issue has been implemented.This device was manufactured prior to the resolutions implemented in the corrective action.

Event Description

The reporter stated the actuator on the rpl450-2 patient lift broke where the actuator attaches to the boom.

• Brand Name: RELIANT 450 POWER LOW BASE LIFT 9153646735
• 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: 17305105
• MDR Text Key: 318971841
• Report Number: 9616091-2023-00015
• 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: Other
• Type of Report: Initial
• Report Date: 07/12/2023

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 Operator: Health Professional
• Device Model Number: NA:RPL450-2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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