MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. RELIANT 600 HD LOW BASE LIFT 9153640382; LIFT, PATIENT, NON-AC-POWERED

Model Number RPL600-1

Device Problem Device Slipped (1584)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 05/13/2014

Event Type  malfunction  

Manufacturer Narrative

Mdr is being submitted as a result of a retrospective complaint review.

Event Description

Mr (b)(6) believes that the nut fell off and the aides didn't realize it.They continued to use it.The customer that was being lifted hit the bed when the screw fell out.The nurses said a bolt fell off last week and they never reported it.Mr.(b)(6) states that he bent the bracket back that accepts that bolt and i did tell him that may weaken that part.

• Brand Name: RELIANT 600 HD LOW BASE LIFT 9153640382
• 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: 5608058
• MDR Text Key: 44221692
• Report Number: 3008262382-2016-00255
• 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: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RPL600-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2014
• 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