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

Model Number NA:RPL450-1

Device Problem Material Erosion (1214)

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

Event Type  malfunction  

Manufacturer Narrative

The allegation of the actuator bolt sheering off the actuator appeared to be confirmed based on the pictures provided.The underlying cause was undetermined.This issue is currently being investigated.It has been previously identified that the cause of the failure in aging devices (outside of their 8-year life expectancy, as is the case with this lift) is likely due to improper maintenance and/or placement of the bushing when the actuator is mounted to the boom.This lift was over 14 years old which is beyond the expected life of 8 years.The lift was manufactured by invacare kunshun which is no longer in operation.The manufacturing location was listed as invamex as they are the currently manufacturing location for this lift model.Multiple attempts were made to obtain further details on the incident, without success.The maintenance safety inspection checklist within the rpl450-1 lift user manual instructs to inspect the hardware connecting the actuator assembly to the mast and boom and to check for wear or deterioration every month.Any defective parts should be replaced immediately.

Event Description

The reporter from a facility called in reporting two workers were raising a patient in the rpl450-1 patient lift when the actuator bolt at the top of the actuator sheered off.The reporter provided pictures of the lift.

• 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: 12439372
• MDR Text Key: 270367430
• Report Number: 9616091-2021-00012
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/03/2021

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: 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: 08/11/2021
• Initial Date FDA Received: 09/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2007
• 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