MAUDE Adverse Event Report: BIOLOGICS INC. AUTO VECTOR FLUID IMMERSION SIMULATION; AIR MATTRESS CONTROL UNIT

Model Number 900T-CU

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pressure Sores (2326)

Event Date 08/16/2014

Event Type  malfunction  

Event Description

It was reported to the manufacturer by the fda medwatch 3500a, per the medwatch form and discussion with the facility, the dolphin mattress is bottoming out.The patient is feeling the bed frame.The patient had bed sores on the lower back and the facility is unsure if they worsened with the use of the dolphin.The dolphin mattress and control unit were exchanged at the facility for another mattress.Complaint (b)(4) were entered into our system to have the control unit returned to joerns for investigation.As of this writing, the control unit has not been returned.

• Brand Name: AUTO VECTOR FLUID IMMERSION SIMULATION
• Type of Device: AIR MATTRESS CONTROL UNIT
• Manufacturer (Section D): BIOLOGICS INC.; clearwater FL
• Manufacturer Contact: felicia banks ; 2100 design rd; arlington, TX 76014 ; 8008260270
• MDR Report Key: 4436338
• MDR Text Key: 21725315
• Report Number: 3009402404-2014-00027
• Device Sequence Number: 1
• Product Code: IKY
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/09/2015

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 Operator: Health Professional
• Device Model Number: 900T-CU
• Device Catalogue Number: 900T-CU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2015
• Distributor Facility Aware Date: 08/16/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2015
• Initial Date Manufacturer Received: 12/12/2014
• Initial Date FDA Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 59 YR
• Patient Weight: 76