MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. POWER LIFT W/LOW BASE-PLUS 9153633519; LIFT, PATIENT, NON-AC-POWERED

Model Number RPL450-1

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2011

Event Type  malfunction  

Manufacturer Narrative

Mdr is being submitted as a result of a retrospective complaint review.The lift was returned for an evaluation.The left tie-rod was bent.The adjustment handle tube was also bent and the weld was broke.The mast was also bent to the right approximately 20 degrees.This type of damage is not typical under normal use conditions.The exact form of abuse is unknown, but engineering stated that this damage can occur when the lift is trapped under a bed and the boom is pulled by attendants or the lift leg is caught on the sling and the lift is raised.Raising the lift with the sling caught underneath could cause the mast and/or tie-rod to bend.Incident is most likely due to user error.

Event Description

The mast allegedly bent to the left side.

• Brand Name: POWER LIFT W/LOW BASE-PLUS 9153633519
• 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: 5685589
• MDR Text Key: 46198063
• Report Number: 3008262382-2016-00358
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/03/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RPL450-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2011
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2011
• Initial Date FDA Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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 Weight: 159