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 reporter stated the shoulder bolt sheared off.They were unsure how the damage occurred.They stated they didn't believe anyone was using the lift and no injury occurred.They had no pictures of the damage available.They were unsure how the damage occurred but believed it was from normal use.

Manufacturer Narrative

This issue is being reported due to should it recur there is a likelihood of the incident resulting in serious injury/death.There was no patient involvement or injury alleged with this incident.The issue would be easily detectable and as it would prevent the lift legs from locking in place.The device was over 6 years old at the time of this issue, the maintenance history of the device is unknown.The device manual has the following statement that may be relevant to this issue.¿when using an adjustable base lift, the legs must be in the maximum opened/locked position before lifting the patient.¿ no further information was available.

• 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: 18005781
• MDR Text Key: 326931386
• Report Number: 9616091-2023-00022
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2023

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 Model Number: NA:RPL450-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• 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