MAUDE Adverse Event Report: RAYES INC. (D/B/A SUNFLOWER MEDICAL L.L.C.) SW IMMERSE; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 61355025

Device Problem Pressure Problem (3012)

Patient Problem Pressure Sores (2326)

Event Date 10/15/2021

Event Type  Injury  

Event Description

"patient did not have certain wounds prior to being placed on immerse.Patient developed 3 wounds within 10-14 days." direct quote from the attached "incident report: (b)(4)".

• Brand Name: SW IMMERSE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): RAYES INC. (D/B/A SUNFLOWER MEDICAL L.L.C.); 206 jefferson st.; ellis KS 67637
• MDR Report Key: 12832814
• MDR Text Key: 280939307
• Report Number: 0001931307-2021-00004
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 61355025
• Device Lot Number: 83362
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/14/2021
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2017
• 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 Weight: 64 KG