MAUDE Adverse Event Report: RAYES, INC. DROP ARM COMMODE; BARIATRIC COMMODE CHAIR

Catalog Number BDAC

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hip Fracture (2349)

Event Date 09/28/2016

Event Type  Injury  

Manufacturer Narrative

Interview with patient family member found they believed patient did not lock arm rest before attempting to use the commode, resulting in the arm rest not working as designed and the patient's injury.A review of pre-placement maintenance records found the device in good working condition.Post-placement inspection found the device to be in good working condition after the incident.Based on record review, inspection, and interview; cause was determined to be improper use of the commode.The patient was provided with a replacement commode to resolve the issue during investigation.When patient was provided with replacement commode, in-service education was provided on proper use of the device.

Event Description

Complainant reported arm rest on bariatric commode failed, resulting in the patient falling and breaking their right hip, requiring surgery.

• Brand Name: DROP ARM COMMODE
• Type of Device: BARIATRIC COMMODE CHAIR
• Manufacturer (Section D): RAYES, INC.; 204 w 2nd st; ellis KS 67637
• Manufacturer (Section G): RAYES, INC.; 204 w 2nd st; ellis KS 67637
• Manufacturer Contact: nicholas rose ; 204 w 2nd street; ellis, KS 67637 ; 8168415391
• MDR Report Key: 6052634
• MDR Text Key: 58244432
• Report Number: 1931307-2016-00003
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: R052095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: BDAC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR