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

Model Number 900T

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Necrosis (1971); No Code Available (3191)

Event Date 08/16/2014

Event Type  malfunction  

Event Description

Pt on "dolphin" immersion mattress.Upon admission, pt had stage 4 to coccyx 2x2x2 cm.It is now 15x20 cm, necrotic and very malodorous.Family did not want pt on a specialty mattress due to sliding.Placed on "dolphin".This mattress bottoms out and pt is on metal bed frame.Convinced family today to change to fluid air sand bed.Tech notified to obtain replacement bed stat.

• Brand Name: DOLPHIN BED
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): JOERNS HEALTHCARE, INC.; 2100 design rd; arlington , TX 76014
• MDR Report Key: 4289596
• MDR Text Key: 5054089
• Report Number: 4289596
• Device Sequence Number: 1
• Product Code: FNM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/06/2014

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: Invalid Data
• Device Model Number: 900T
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2014
• Patient Sequence Number: 1
• Patient Age: 59 YR