MAUDE Adverse Event Report: INVAMEX POWER LIFT W/LOW BASE-PLUS 9153633519; LIFT, PATIENT, AC-POWERED

Model Number NA:RPL450-1

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

The bolt in the hanger bar of the patient lift came out resulting in the hanger bar and user in the sling falling in the middle of a transfer.The user was roughly 3 inches above the arms of a chair when they fell.The user was transported to a hospital for evaluation but had no apparent injuries.The device was taken out of use.

Manufacturer Narrative

Multiple attempts were made to obtain additional information regarding this incident, without success.The device was over 13 years old at the time of this incident.The user¿s weight was within the weight capacity of 450 pounds listed in the manual.This incident has been previously investigated via a corrective action.Contributing factors including inadequate joint design were found to be the most likely cause of this failure.Corrections are actively being implemented.

• Brand Name: POWER LIFT W/LOW BASE-PLUS 9153633519
• 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: 15074139
• MDR Text Key: 298587071
• Report Number: 9616091-2022-00012
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/14/2022

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:RPL450-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2009
• 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 Weight: 70 KG