MAUDE Adverse Event Report: DRIVE MEDICAL SENTRA; WHEELCHAIR, MECHANICAL

Model Number DRIVE MEDICAL SENTRA RECLINING WHEELCHAIR

Device Problems Disconnection (1171); Inadequacy of Device Shape and/or Size (1583); Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2020

Event Type  malfunction  

Event Description

Chair is too wide, cushion is too small for patient, there is no head rest cushion, brake on left side in front is not connected to the wheel.Patient was close to falling, but did not fall.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SENTRA
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): DRIVE MEDICAL
• MDR Report Key: 17529074
• MDR Text Key: 321237253
• Report Number: MW5136003
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: DRIVE MEDICAL SENTRA RECLINING WHEELCHAIR
• Patient Sequence Number: 1