MAUDE Adverse Event Report: THREE BEARS(JIANGSU)HEALTHCARE TECHNOLOGY CO.,LTD STAXI TRANSPORT CHAIR; CHAIR, ADJUSTABLE, MECHANICAL

Patient Problem Fall (1848)

Event Date 11/09/2023

Event Type  malfunction  

Event Description

Family obtained wheelchair from hospital and took it out to the parking lot to retrieve visitor from their vehicle.While wheeling the patient across the handicap part of the sidewalk, the wheelchair wheel broke, and the visitor fell to the ground.Manufacturer response for wheelchair, staxi transport chair (per site reporter).Facilities manager was making the manufacturer aware by ordering a new wheel.

• Brand Name: STAXI TRANSPORT CHAIR
• Type of Device: CHAIR, ADJUSTABLE, MECHANICAL
• Manufacturer (Section D): THREE BEARS(JIANGSU)HEALTHCARE TECHNOLOGY CO.,LTD; 8 willington way; newnan GA 30265
• MDR Report Key: 18911848
• MDR Text Key: 337750208
• Report Number: 18911848
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 145 KG
• Patient Race: White