MAUDE Adverse Event Report: INVACARE SUZHOU NON AC-POWERED PATIENT LIFT; 880.5510

Model Number GHS350

Device Problems Material Separation (1562); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that bolts from the lift are lost and the lift has come apart.

• Brand Name: NON AC-POWERED PATIENT LIFT
• Type of Device: 880.5510
• Manufacturer (Section D): INVACARE SUZHOU; unit 28 zone,200 suhong rd; suzhou industrial park; jiangsu, p.r.c. 2150 21; CH 215021
• Manufacturer (Section G): INVACARE SUZHOU; unit 28 zone,200 suhong rd; suzhou industrial park; jiangsu, p.r.c. 2150 21; CH 215021
• Manufacturer Contact: patricia medina ; one invacare way; elyria, OH 44035 ; 9999999999
• MDR Report Key: 3575273
• MDR Text Key: 19480195
• Report Number: 3004493922-2014-00074
• 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
• Type of Report: Initial
• Report Date: 01/07/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 01/07/2014
• 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
• Patient Outcome(s): Other