MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. HYDRAULIC LIFT W/LOW BASE-PLUS 9153633521; LIFT, PATIENT, NON-AC-POWERED

Model Number 9805

Device Problem Bent (1059)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The dealer stated that the unit has a leg that is bent.He states that he just received lift back from rental, the left side is bent up 3" above ground.The dealer states that some places it was welded looks like the it was re welded.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.The result of the evaluation was that the left leg was bent upward a significant amount, which confirmed the original complaint issue.But no bad welds could be identified.The underlying cause of the complaint issue could not be determined.However, it was noted that the camlock weldment (where the handle for opening/closing the legs mounts) had been disassembled from the base and once reassembled, the legs functioned normally.No manufacturing defects were identified.

Event Description

The dealer stated that the unit has a leg that is bent.He states that he just received lift back from rental, the left side is bent up 3 above ground.The dealer states that some places it was welded looks like the it was re welded.

• Brand Name: HYDRAULIC LIFT W/LOW BASE-PLUS 9153633521
• 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: 5359636
• MDR Text Key: 35982485
• Report Number: 3008262382-2016-00024
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/07/2016

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: 9805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2015
• Initial Date FDA Received: 01/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2016
• 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