MAUDE Adverse Event Report: JOERNS HEALTHCARE, INC. DOLPHIN FLUID IMMERSION SIMULATION; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 900T - CU -U

Device Problems Product Quality Problem (1506); Protective Measures Problem (3015); Unintended Deflation (4061)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/03/2023

Event Type  malfunction  

Event Description

Patient has dolphin bed for known pressure injury.Floor nurse reports bed was deflated and in stand-by mode for the last two nights.Unit is currently plugged in to the bed.Agiliti was contacted earlier this week for another dolphin bed in another patient room and stated this is a known issue.Call was made to agility again this am to report this patient's bed issues to have them re-check it.

• Brand Name: DOLPHIN FLUID IMMERSION SIMULATION
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): JOERNS HEALTHCARE, INC.; 2100 design rd; arlington TX 76014
• MDR Report Key: 16960660
• MDR Text Key: 315548509
• Report Number: 16960660
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 900T - CU -U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/03/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other