MAUDE Adverse Event Report: INVACARE TAYLOR STREET TDX SP2 BASE FOR REHAB SEATING; WHEELCHAIR, POWERED

Model Number NA:TDXSP2

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

Invacare was made aware of an event that occurred in denmark with a tdxsp2 power wheelchair.This medwatch is being filed in an abundance of caution due to the us manufactured tdxsp2 wheelchair being similar in design and would likely have the same outcome as this event.It is unknown what and if any malfunction occurred.It is unknown exactly how the incident occurred and/or what may have caused it.Photos and additional information have been requested.If further information becomes available a follow-up medwatch will be filed.

Event Description

It was reported a resident broke his ankle when his foot became stuck against the elevator wall while in a tdxsp2 power wheelchair.The wheelchair was being driven by an attendant when the incident occurred.It was noted the attendant has previously driven similar wheelchairs but does not have much experience and the wheelchair could not maneuver as usual.The resident sometimes experiences leg spasms.At the time of the incident the resident¿s foot was strapped to the footrest.It was subsequently observed the top of his foot extends past the foot plate and it was possible his foot rotated outwards off the footrest.

• Brand Name: TDX SP2 BASE FOR REHAB SEATING
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: micheal simmons ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 19141929
• MDR Text Key: 340566876
• Report Number: 1525712-2024-00004
• 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: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:TDXSP2
• Device Catalogue Number: TDXSP2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2024
• 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
• Patient Sex: Male
• Patient Weight: 96 KG