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

Model Number NA:RPL450-2

Device Problem Unintended System Motion (1430)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, the complaint could not be verified, and a device malfunction cannot be confirmed.The underlying cause of the boom dropping could not be determined.A return of the lift was requested, however, the facility will not return it, therefore, it is not known if the lift malfunctioned, or if it was user error that caused the mast to fall.This event has not been determined to be the result of a device malfunction.This lift was manufactured by (b)(4).However, they are no longer in business.The manufacturer of these lifts has since been transitioned to invamex.Therefore, the mdr is being filed under invamex.

Event Description

The facility was using an rpl450-2 lift to get the resident out of bed.They had her over a wheelchair when the mast went down without them trying to lower it.The resident fell down into the chair and the mast hit her in the forehead.The patient went to the er, where she received 3 stitches in her head, and was released.The product has been taken out of use.

• Brand Name: RELIANT 450 POWER LOW BASE LIFT 9153646735
• Type of Device: LIFT, PATIENT, AC-POWERED
• Manufacturer (Section D): INVAMEX MANUFACTURING; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX MANUFACTURING; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 9587802
• MDR Text Key: 189037252
• Report Number: 9616091-2020-00005
• 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: distributor,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:RPL450-2
• Device Catalogue Number: RPL450-2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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
• Patient Outcome(s): Required Intervention