MAUDE Adverse Event Report: PRISM MEDICAL MEDCARE 475 LB LIFT

Model Number 400001

Device Problems Inadequate Service (1564); Device Tipped Over (2589)

Patient Problems Abrasion (1689); Headache (1880)

Event Date 11/21/2014

Event Type  malfunction  

Event Description

Two caregivers were transferring a pt when one of the legs hit a wheelchair and closed the legs, causing the lift to tip over.The pt wasn't very high in the air at the time and was caught by one of the caregivers.The boom slightly scraped the pt on the forehead; he went to the emergency room with a headache and was administered tylenol.

Manufacturer Narrative

Quality assurance technician went to the facility on (b)(4) 2014 to do a safety inspection.He found the leg bolt on this unit to be loose, causing the legs to pivot easily.He tightened them and instructed the facility regarding recommended preventative maintenance intervals.In addition, he inspected the others lifts at the location.

• Brand Name: MEDCARE 475 LB LIFT
• Type of Device: MEDCARE 475 LB LIFT
• Manufacturer (Section D): PRISM MEDICAL; maryland heights MO
• Manufacturer Contact: jeff matthews ; 10888 metro ct; maryland heights, MO 63043 ; 3146929135
• MDR Report Key: 4379776
• MDR Text Key: 5238552
• Report Number: 3007802293-2014-00034
• 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
• Type of Report: Initial
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400001
• Was Device Available for Evaluation?: Yes
• 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