MAUDE Adverse Event Report: INVACARE TAYLOR STREET POWER LIFT W/LOW BASE-PLUS 9153633519; LIFT, PATIENT, NON-AC-POWERED

Model Number NA:RPL450-1

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Death (1802)

Event Date 03/05/2018

Event Type  Death  

Manufacturer Narrative

Based on the limited information provided, a device malfunction cannot be confirmed.The complaint could not be verified, and the underlying cause could not be determined.The rpl450-1 power lift is/has been manufactured by invamex, invacare (b)(4), and invacare rehabilitation equipment co.(suzhou); but because the serial number is not known, this medwatch is being filed under invacare (b)(4).The invacare reliant rpl450-1 user manual states, "after any adjustments, repair or service and before use, make sure all attaching hardware is tightened securely - otherwise, injury or damage may occur." additionally, the maintenance safety inspection checklist states to inspect/adjust monthly the boom: check all hardware and hanger bar supports, and the hanger bar: check the bolt/hooks for wear or damage.Should additional information become available, a supplemental record will be filed.

Event Description

This complaint was discovered during a monthly check of the maude database, invacare has received no other information concerning this event.It is alleged two staff members were attempting to transfer a patient from a bed to a wheelchair, using an rpl450-1 power lift, the cradle became detached from the boom.The individual fell hitting their head on the base, and the cradle landed on the individual.It allegedly caused internal injuries that led to death.

• Brand Name: POWER LIFT W/LOW BASE-PLUS 9153633519
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 7605364
• MDR Text Key: 111177277
• Report Number: 1525712-2018-00041
• 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: other
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: NA:RPL450-1
• Device Catalogue Number: RPL450-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death