MAUDE Adverse Event Report: GOLDEN TECHNOLOGIES, INC. GOLDEN COMPASS PRO; POWER WHEELCHAIR

Model Number GP61M-STD-BLU

Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)

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

Event Date 12/01/2012

Event Type  Injury  

Event Description

Caller reported her wheelchair has stopped abruptly in the middle of the street several times, endangering her life.The device was purchased on (b)(6) 2010 and worked efficiently for 2 years.Then in (b)(6) 2012 the battery and wheels were replaced; after this date the wheelchair began to malfunction regularly.Several techs were sent and replaced various components of the device but the issue was never resolved.Caller reported instead of alleviating the malfunction techs would cause more issues, i.E., screws and pins falling.Caller is worried for her safety and is looking for support.

Event Description

Add'l info received on 01/11/2018 for report #mw5073925.Reporter states that on (b)(6) 2017 she was at the dentist office; she tripped and fell as she got out of her wheelchair.She injured her head, shoulder and fractured her humerus.As a result, she was hospitalized for one week and acquired influenza, pneumonia and missed receiving treatment at her dentist appointment.Reporter states that she is not sure if the wheel of the wheelchair or, if it was the foot rest that caused her to trip.

• Brand Name: GOLDEN COMPASS PRO
• Type of Device: POWER WHEELCHAIR
• Manufacturer (Section D): GOLDEN TECHNOLOGIES, INC.
• MDR Report Key: 7112048
• MDR Text Key: 94824851
• Report Number: MW5073925
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: GP61M-STD-BLU
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 66 YR