MAUDE Adverse Event Report: DRIVE DRIVE HIGH BACK WHEELCHAIR

Model Number 4S1301120563

Device Problems Mechanical Problem (1384); Material Separation (1562); Device Operates Differently Than Expected (2913)

Patient Problem Head Injury (1879)

Event Date 08/13/2016

Event Type  Injury  

Event Description

Pt was sitting in a high back reclining back wheelchair.Was seen by therapy, nursing staff, pt was fine in wheelchair.As pt was wheeling by the nurse area, the back of the wheelchair released, reclining all the way back and resident went backwards in the chair, hitting her head.Dates of use: 3 years.Diagnosis or reason for use: multiple sclerosis.

• Brand Name: DRIVE HIGH BACK WHEELCHAIR
• Type of Device: HIGH BACK WHEELCHAIR
• Manufacturer (Section D): DRIVE; port washington NY 11050
• MDR Report Key: 5885415
• MDR Text Key: 52504835
• Report Number: MW5064161
• Device Sequence Number: 1
• Product Code: IMP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4S1301120563
• Device Lot Number: SSP18RBDDA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Weight: 112