MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. HYDRAULIC LIFT W/ADJ BASE 9153629360; LIFT, PATIENT, NON-AC-POWERED

Model Number 9805

Device Problems Bent (1059); Collapse (1099); Device Slipped (1584)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Provider states the home health nurse mentioned there could be an issue with the pump holding.Provider was made aware by the home health nurse that the patient's aid got the patient in the lift, the carriage bolt in the base did not hold causing the lift legs to collapse in and the patient to fall, she had to go to the er, doctors found no broken bones, they are watching her for a concussion, and she is very sore from the fall.Provider was made aware that the locking pin is completely bent after this incident, the husband advised they have always had issues with the locking pin, provider states they were never made aware of these issues with the pin.Provider states they have a lift in stock they are going to give the patient to use, when we have the lift available again we can replenish their stock with a unit.No additional information provided.Update from 01/13/2016 added by consumer affairs: product is being returned and was replaced by provider.Patient was seen in the er and received x-rays and medication for the pain but they did not find any broken bones.No further information has been provided at this time.

• Brand Name: HYDRAULIC LIFT W/ADJ BASE 9153629360
• 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: 5366378
• MDR Text Key: 35963079
• Report Number: 3008262382-2016-00046
• 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
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Hospitalization
• Patient Weight: 163