MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. GET-U-UP HYDRAULIC STAND-UP LIFT 9153648036; LIFT, PATIENT, NON-AC-POWERED

Model Number GHS350

Device Problem Material Integrity Problem (2978)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  malfunction  

Event Description

It was reported that the handgrips for the lift arms on a ghs350 get-u-up hydraulic lift are rough, not smooth.User sustained scrapes to her hands while assembling the lift.No alleged medical intervention.

• Brand Name: GET-U-UP HYDRAULIC STAND-UP LIFT 9153648036
• 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: 4683308
• MDR Text Key: 5673293
• Report Number: 3008262382-2015-01092
• 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: Consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/08/2015

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: GHS350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 04/13/2015
• 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): Other