MAUDE Adverse Event Report: SHANGHAI HUBANG MEDICAL APPLIANCES CO LTD FEATHERLIGHT TRANSPORT CHAIR; TRANSPORT CHAIR, INVALID CHAIR

Model Number DC150111

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2016

Event Type  malfunction  

Event Description

Patient bought this transport chair at a garage sale and brought it to a (b)(4) for servicing and wanted a replacement front fork assembly.Upon inspection, the service tech determined that the caster stud was bent and the threads were damaged and he could not safely repair the chair.There was no critical event or injury, absent information, event date is date of this report.

• Brand Name: FEATHERLIGHT TRANSPORT CHAIR
• Type of Device: TRANSPORT CHAIR, INVALID CHAIR
• Manufacturer (Section D): SHANGHAI HUBANG MEDICAL APPLIANCES CO LTD; no. 1188 xiangyang road; min hang district; shanghai, 20110 8; CH 201108
• MDR Report Key: 5851646
• MDR Text Key: 51343186
• Report Number: 1056127-2016-00010
• Device Sequence Number: 1
• Product Code: INN
• UDI-Device Identifier: 00754756140038
• UDI-Public: 754756140038
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/05/2016,07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: DC150111
• Device Catalogue Number: H3005BK
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/18/2016
• Device Age: 8 YR
• Date Report to Manufacturer: 08/05/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 73