MAUDE Adverse Event Report: AMERICAN NATIONAL DOLPHIN FLUID IMMERSION SYSTEM; DOLPHIN SYSTEM

Model Number DLPH-35820000J-M

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

Patient Problem Fall (1848)

Event Date 08/28/2015

Event Type  Injury  

Manufacturer Narrative

Joerns sending the report to the manufacturer.

Event Description

It was reported to the manufacturer by the end user, per the end user (b)(6) (user facility) called (b)(6) ((b)(4) of long term care for joerns) informing him patient had fallen out of bed and required medical attention at local hospital.(b)(6) called customer service to have dolphin pump and mattress swapped for a dflal and existing dolphin pump and mattress put in local storage room until coverlet would be brought up next week.Spoke with (b)(6) (field service technician) after he arrived, was on site within an hour after call came in and did has instructed by (b)(6).Will not put same product under patient, will pick up and returned to warehouse for thorough inspection (b)(4) were entered into our system to have the dolphin control unit and mattress returned to joerns for investigation.The dolphin control unit and mattress were returned on 09/11/2015 and are awaiting investigation.

• Brand Name: DOLPHIN FLUID IMMERSION SYSTEM
• Type of Device: DOLPHIN SYSTEM
• Manufacturer (Section D): AMERICAN NATIONAL; 252 mariah circle; corona CA 92879
• Manufacturer (Section G): AMERICAN NATIONAL; 252 mariah circle; corona CA 92879
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 5109200
• MDR Text Key: 26938730
• Report Number: 3009402404-2015-00030
• 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: health professional
• Reporter Occupation: Health Professional
• Report Date: 09/28/2015

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-35820000J-M
• Device Catalogue Number: DLPH-35820000J-M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: No
• 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: 78 YR