MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. ILIFT HYDRAULIC LIFT 9153652760; LIFT, PATIENT, NON-AC-POWERED

Model Number ILIFTEM

Device Problem Bent (1059)

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

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

Event Description

Provider states the enduser alleges the linkage rod is bending.Tech adjusted the tension on the linkage rod on right side and the left side keeps bending.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: patient transport.Other, other/defective.Left side tie rod unattached and bent badly/also two additional tie rods in carton/both bent/no other manufacturing defects found.Complaint was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

Product was returned for evaluation.The return fields in oracle state: patient transport.Other, other/defective.Left side tie rod unattached and bent badly/also two additional tie rods in carton/both bent/no other manufacturing defects found.Provider states the enduser alleges the linkage rod is bending.Tech adjusted the tension on the linkage rod on right side and the left side keeps bending.

• Brand Name: ILIFT HYDRAULIC LIFT 9153652760
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): INVACARE REHABILITATION EQUIPMENT CO.; no.5 weixi road, sip; suzhou jiangsu 21512 1; CH 215121
• Manufacturer (Section G): INVACARE REHABILITATION EQUIPMENT CO.; no.5 weixi road, sip; suzhou jiangsu 21512 1; CH 215121
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5331527
• MDR Text Key: 35036105
• Report Number: 3008262382-2015-02071
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/19/2016

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: Lay User/Patient
• Device Model Number: ILIFTEM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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