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); Device Tipped Over (2589)

Patient Problems Fall (1848); Injury (2348)

Event Date 03/16/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Reporter advised staff was putting end user in bed and front caster bent inward and tipped over with end user in lift.Reporter advised aide tried to stop end user from falling and they both fell to the floor.Reporter advised there was no injury to end user but aide pulled a muscle in one of her legs.Reporter advised aide went to (b)(6) and they took x rays and advised she had pulled a muscle and prescribed muscle relaxer pain pills and advised to do physical therapy.Reporter advised aide is currently or just finished physical therapy.Reporter advised aide was advised to return to work on (b)(6) 2016 with restrictions but due to the nature of the work she has been off work since issue happened.Reporter advised not aware of end user weight.

• 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: 5646393
• MDR Text Key: 44981467
• Report Number: 3008262382-2016-00383
• 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: user facility
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 05/05/2016

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: 9805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2016
• Initial Date FDA Received: 05/11/2016
• 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