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

Model Number DLPH-000000DMU-CU

Device Problem Inflation Problem (1310)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2018

Event Type  malfunction  

Event Description

Dolphin pump alarming "fault".Pump was replaced by universal health services (uhs).New pump then also alarmed "fault" and mattress would not inflate, leaving patient lying on hard surface of bed frame for approximately 2 hours and at high risk of pressure related skin injury.

• Brand Name: DOLPHIN FLUID IMMERSION SYSTEM
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): JOERNS HEALTHCARE, INC.; 2100 design rd; arlington TX 76014
• MDR Report Key: 8073001
• MDR Text Key: 127226773
• Report Number: 8073001
• 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: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DLPH-000000DMU-CU
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10220 DA