MAUDE Adverse Event Report: SHOPRIDER 6 RUNNER 14 HD; WHEELCHAIR, POWERED

Model Number 888WNLLHD

Device Problem Unintended Collision (1429)

Patient Problem Hip Fracture (2349)

Event Date 01/31/2014

Event Type  Injury  

Event Description

Resident sustained right femur fracture after self-propelling electric power chair resident ran chair into wall.

• Brand Name: 6 RUNNER 14 HD
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): SHOPRIDER
• MDR Report Key: 3639465
• MDR Text Key: 4209096
• Report Number: MW5034591
• Device Sequence Number: 1
• Product Code: INI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 888WNLLHD
• Device Lot Number: IWN14C41A0095
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Weight: 96