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

Model Number NA:RPL600-1

Device Problems Break (1069); Collapse (1099)

Patient Problem Fall (1848)

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

This issue is being reported in an abundance of caution.The underlying cause of the issue couldn¿t be determined.The facility is unwilling to return the actuator in question or provide any further information regarding this incident.A picture was provided confirming the buckling of the actuator, but it is unclear if use error or a deficiency caused the issue.The lift was past the end of life of 8 years, however, the actuator is within the wear and tear period of 2 years.This device was manufactured by invacare suzhou which is no longer in operation.The manufacturing location will be listed as invamex as that is the current manufacturing location for this model of lift.

Event Description

The lift boom actuator buckled in half and the lift failed causing the user to fall.The user was taken to the hospital and evaluated, only soreness was reported.

• 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: 12376853
• MDR Text Key: 268445548
• Report Number: 9616091-2021-00011
• 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
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2021

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: No Information
• Device Model Number: NA:RPL600-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2011
• 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