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 Component (1104)

Patient Problem Death (1802)

Event Date 03/05/2018

Event Type  Death  

Manufacturer Narrative

Invacare is filing this medwatch in an abundance of caution due to the severity of the outcome.Attempts to contact the facility and therapist present at the time of the incident have not been answered.The lift has not been returned for evaluation, nor further information about the incident has been obtained.Based on the information provided, a device malfunction cannot be confirmed.The complaint could not be verified, and the underlying cause could not be determined.The invacare reliant rpl450-1 user manual states, "after any adjustments, repair or service and before use, make sure all 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.The rpl450-1 power lift is manufactured by (b)(4); but because the serial number is not known, this medwatch is being filed under invacare taylor street.Should additional information become available, a supplemental record will be filed.

Event Description

The institution rep relates when attempting to transfer a patient the nut that holds the hanger bar in place backed out and the end-user fell to the floor.The end-user later died at the hospital.The caller relates he doesn't have the specific information regarding the end-users injuries.

• 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: 7382949
• MDR Text Key: 103886459
• Report Number: 1525712-2018-00033
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2018

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?: No
• Device Operator: Other Health Care Professional
• Device Model Number: NA:RPL450-1
• Device Catalogue Number: RPL450-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2018
• Initial Date FDA Received: 03/29/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death