MAUDE Adverse Event Report: INVAMEX HYDRAULIC LIFT W/ADJ BASE BEIGE POWDERCOAT 9153644679; LIFT, PATIENT, NON-AC-POWERED

Model Number 9805P

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The dealer stated that the lift was being used at the patient's home.The patient reported that the lift was tipping over due to the casters being uneven.The dealer indicated that upon inspection of the lift, he determined that the base frame was bent, causing the front right caster to be elevated off of the floor.The dealer had no details on how the frame became bent.Since the manufacture of this device, updates to the material and dimensions for the legs and updates to incoming inspections of the legs have been implemented.The lift was not returned to invacare for evaluation.The dealer provided the patient with a new lift.Should additional information become available, a supplemental record will be filed.The 9805p hydraulic lift was manufactured by invacare rehabilitation equipment co.((b)(4)); however, they are no longer in business.The manufacture of these lifts has transitioned to invamex.

Event Description

The dealer reported that the front right caster is up in the air.

• Brand Name: HYDRAULIC LIFT W/ADJ BASE BEIGE POWDERCOAT 9153644679
• Type of Device: LIFT, PATIENT, NON-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: 7032684
• MDR Text Key: 92846366
• Report Number: 9616091-2017-00006
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: 9805P
• Device Catalogue Number: 9805P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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: 136