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

Model Number RPL450-1

Device Problems Bent (1059); Entrapment of Device (1212); Device Tipped Over (2589); Device Operates Differently Than Expected (2913); Fail-Safe Problem (2936); Positioning Problem (3009); Unintended Movement (3026)

Patient Problems Fall (1848); Injury (2348); Skin Tears (2516)

Event Date 05/05/2016

Event Type  Injury  

Manufacturer Narrative

Return material authorization has been issued for the return of this device for investigation; return not yet received.Investigation to be completed when the device is returned.The user¿s manual states that regular maintenance of patient lifts and accessories is necessary to assure proper operation.No injury to the end user was reported.There is insufficient information regarding the event that led to the serious injury allegation; unknown how the caretaker injured their knee moving the lift.Multiple attempts have been made for additional information regarding the alleged event.If additional information should become available, this record will be updated accordingly.

Event Description

The caller states the lift malfunctioned, she states she thinks that the lift is hard to turn or the legs are not latching properly in the open position.She also states the boom arm bent when the lift malfunctioned and was caught under the bed.She states the lift tipped over and the end user slid down the wall to the floor with no injuries.She states the caretaker hurt her knee trying to move the lift out of the way; acl (anterior cruciate ligament) tear and surgery.She also states they do not have the safety hooks (hanger bar latch) on the lift and have been trying to get them and have not been able to get them.No other information.

• 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: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5825464
• MDR Text Key: 50523053
• Report Number: 1525712-2016-02509
• 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: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RPL450-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2016
• 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): Required Intervention