MAUDE Adverse Event Report: INVAMEX NLA NO RPLMT POWER LIFT-W/ADJ BASE-PLUS 9153633520; LIFT, PATIENT, AC-POWERED

Model Number NA:RPA450-1

Device Problem Device Fell (4014)

Patient Problem Laceration(s) (1946)

Event Date 05/27/2022

Event Type  Injury  

Manufacturer Narrative

This incident is being reported in an abundance of caution.The exact details of this incident are unclear.However, the reporter indicated the sling was potentially undersized for the user, and based on the incident description it is unclear if the lift was properly centered.Either issue could have played a roll in this incident.The user weighed 330 pounds which is within the weight capacity of 450 pounds.Multiple attempts were made to obtain clarification of the incident, without success.The manufacturing location is no longer in operation.Due to the manufacturing location no longer being in operation the medwatch will be filed using the devices last manufacturing location which was invamex.

Event Description

The patient was being transported from bed to wheelchair using rpa450-1 lift.There were 2 staff members participating in transfer-lift legs were positioned with one leg under wheelchair and one leg on side of chair.Patient was being lowered into the wheelchair, when the lift tipped over onto it's side.There was an ot outside of door that came in to stop lift from landing on patient's head.Patient dropped quickly into the wheelchair, causing large gash on leg that required er visit and stitches.There were also skin tears to arm that did not require medical attention.Caller was not on site when issue occurred.

• Brand Name: NLA NO RPLMT POWER LIFT-W/ADJ BASE-PLUS 9153633520
• 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: 14934671
• MDR Text Key: 295357327
• Report Number: 9616091-2022-00010
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/29/2022

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: Health Professional
• Device Model Number: NA:RPA450-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2022
• Initial Date FDA Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 150 KG