MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. HYDRAULIC LIFT W/ADJ BASE BEIGE POWDERCOAT 9153644679; LIFT, PATIENT, NON-AC-POWERED

Model Number 9805P

Device Problem Bent (1059)

Patient Problems Fall (1848); Concussion (2192)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

Should additional information become available, a supplemental record will be filed.User¿s manual review (1024492 rev.E, page 12).Casters and axle bolts require inspections every six months to check for tightness and wear.Regular maintenance of patient lifts and accessories is necessary to assure proper operation.

Event Description

The provider states the consumer alleged the wheel crumbled/bent and the lift tilted with the patient in it and the end user fell to the floor.The caregiver rushed the end user to the hospital.The end user had x-rays on her left leg and her head.The end user had preexisting left tibia and fibula fracture and a right ankle sprain before receiving the lift.The end user was allegedly diagnosed with a concussion and was released to her home with daughter who is the primary caregiver.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: patient transport.Wheel/casters, hold for detailed evaluation.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed.The right support leg of the 9805p invacare hydraulic lift in question was bent.The bend in the leg of the lift caused the front right caster to not contact the ground, which made the lift unstable.Complaint was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.User¿s manual review (1024492 rev.E, page 12) casters and axle bolts require inspections every six months to check for tightness and wear.Regular maintenance of patient lifts and accessories is necessary to assure proper operation.

Event Description

Product was returned for evaluation.The return fields in oracle state: patient transport.Wheel/casters, hold for detailed evaluation.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed.The right support leg of the 9805p invacare hydraulic lift in question was bent.The bend in the leg of the lift caused the front right caster to not contact the ground, which made the lift unstable.Update from 01/25/2016 added by consumer affairs: end user stated dealer replaced her lift with a heavy duty lift since she is (b)(6) pounds and it is working much better.She said she thinks the lift leg folded because she is so big.She did not cause further injury to her leg, she did have a mild concussion but is doing ok from the fall.She is happy with the new lift.No further information provided or expected.The provider states the consumer alleged the wheel crumbled/bent and the lift tilted with the patient in it and the end user fell to the floor.The caregiver rushed the end user to the hospital.The end user had x-rays on her left leg and her head.The end user had preexisting left tibia and fibula fracture and a right ankle sprain before receiving the lift.The end user was allegedly diagnosed with a concussion and was released to her home with daughter who is the primary caregiver.

• Brand Name: HYDRAULIC LIFT W/ADJ BASE BEIGE POWDERCOAT 9153644679
• 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: 5362928
• MDR Text Key: 35744087
• Report Number: 3008262382-2016-00035
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• 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: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9805P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2016
• Initial Date FDA Received: 01/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2016
• 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
• Patient Outcome(s): Hospitalization
• Patient Weight: 181