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

Model Number 900T-CU

Device Problems Energy Output Problem (1431); Product Quality Problem (1506); Protective Measures Problem (3015)

Patient Problem Pressure Sores (2326)

Event Date 05/03/2023

Event Type  malfunction  

Event Description

Patient has dolphin bed for known pressure injury.Within the last 7 days there is worsening of her pressure injury due to dolphin mattress malfunction.Agiliti (equipment manager) was called at that time to inspect mattress.They recommended unit be plugged into the wall, which was done.Rns went to patient room to follow up on wounds today, but patient was gone from her room for a procedure.Rns looked at bed which was again in standby.Unit was plugged in to the wall at this time.Call was made to agiliti to report this patient's bed issues and another patient in a separate room whose dolphin bed was having the same issue 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: 16960691
• MDR Text Key: 315548787
• Report Number: 16960691
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 900T-CU
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 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