MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. POWER STAND-UP LIFT-PLUS 9153633660; LIFT, PATIENT, NON-AC-POWERED

Model Number RPS350-1

Device Problems Component Missing (2306); Out-Of-Box Failure (2311); Dent in Material (2526)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The provider states the welded index plate was missing from the cross support.The provider states the box only had a dent in it and states there wasn't a loose piece of metal to indicate a break.The provider states this is an out of box failure with no consumer involvement.

Manufacturer Narrative

Follow up to be sent if additional information is received.

• Brand Name: POWER STAND-UP LIFT-PLUS 9153633660
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): INVACARE REHABILITATION EQUIPMENT CO.; no.5 weixi road, sip; suzhou jiangsu 2151 21; CH 215121
• Manufacturer (Section G): INVACARE REHABILITATION EQUIPMENT CO.; no.5 weixi road, sip; suzhou jiangsu 2151 21; CH 215121
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4837864
• MDR Text Key: 5931571
• Report Number: 3008262382-2015-01332
• 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: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RPS350-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2015
• 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 Outcome(s): Other