MAUDE Adverse Event Report: JOERNS HEALTHCARE FLUID IMMERSION SYSTEM; AIR MATTRESS AND PUMP

Model Number DLPH-3582OOOOJ-M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Hematoma (1884); Skin Tears (2516)

Event Date 03/11/2015

Event Type  Injury  

Event Description

It was reported to the manufacturer by the facility (b)(6), per the facility the resident rolled out of bed and landed on the floor.The resident sustained a hematoma to the right temple/forehead and a skin tear to the right arm.The patient was sent to the hospital for evaluation and x-rays.She returned to the facility the same day.Complaint (b)(4) were entered into our system to have the dolphin system returned to joerns for investigation.As of this writing, the dolphin system has not been returned.

Manufacturer Narrative

• Brand Name: FLUID IMMERSION SYSTEM
• Type of Device: AIR MATTRESS AND PUMP
• Manufacturer (Section D): JOERNS HEALTHCARE; arlington TX
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 4640410
• MDR Text Key: 5614906
• Report Number: 3009402404-2015-00007
• 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
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DLPH-3582OOOOJ-M
• Device Catalogue Number: DLPH-3582OOOOJ-M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2015
• Distributor Facility Aware Date: 03/11/2015
• Device Age: 3 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/23/2015
• Initial Date Manufacturer Received: 03/12/2015
• Initial Date FDA Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2012
• 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
• Patient Age: 87 YR
• Patient Weight: 59