MAUDE Adverse Event Report: MERITS HEALTH PRODUCTS., INC. MERITS VISION SPORT POWER WHEELCHAIR; WHEELCHAIR, POWERED

Model Number P326A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 04/08/2023

Event Type  Death  

Event Description

Expired resident found positioned between power wheelchair armrest and seat.Staff needed to remove armrest in order to release body.Expired resident found to have slid off the right side of his chair in the space between the flip up arm rest and his wheelchair seat.His bottom and feet were on the floor.His wheelchair cushion had slid down over the edge of the power wheelchair and was pressing against his neck and back.His right upper extremity was wrapped around the outer side of the rear support bar between the right arm rest and back rest.His chin was resting upon the arm rest.M.E.(medical examiner) contacted and declined jurisdiction due to belief that death was likely a natural event.Ref report: mw5117036.

• Brand Name: MERITS VISION SPORT POWER WHEELCHAIR
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): MERITS HEALTH PRODUCTS., INC.
• MDR Report Key: 16816052
• MDR Text Key: 314036657
• Report Number: MW5117035
• 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: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: P326A
• 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): Death
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White