MAUDE Adverse Event Report: RAZ DESIGN INC. RAE MOBILE SHOWER COMMODE CHAIR; CHAIR ADJUSTABLE MECHANICAL

Device Problem Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2019

Event Type  malfunction  

Event Description

Pt with history of cervical spinal cord injury and quadriparesis was placed in shower chair and rolled into shower by a staff member.When staff shifted pt in order to have her sit straight, the chair cushion fell through the hole in the frame.No injury to the pt.

• Brand Name: RAE MOBILE SHOWER COMMODE CHAIR
• Type of Device: CHAIR ADJUSTABLE MECHANICAL
• Manufacturer (Section D): RAZ DESIGN INC.; niagara falls NY
• MDR Report Key: 8273995
• MDR Text Key: 134195719
• Report Number: MW5083316
• Device Sequence Number: 0
• Product Code: INN
• Combination Product (y/n): N
• 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: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR