MAUDE Adverse Event Report: JOERNS HEALTHCARE DERMAFLOAT LAL SYSTEM; PATIENT AIR MATTRESS

Model Number DFLAL-3680-M

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

Patient Problem Burn(s) (1757)

Event Date 06/30/2018

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user "resident was lying in her bed with her oxygen tubing off of her face and it was off to the left side of her face.The flames were coming from the sheet by her left side, the left side of resident gown, oxygen concentrator, cloth pad on the floor next to the concentrator, and the oxygen tubing.Resident repeated several times "all i wanted was a damn cigarette, my dog died." the resident was transported to the hospital with burns.(b)(4) were entered into our system to have the mattress and control unit returned to joerns for investigation.The mattress and control unit was receive at joerns (b)(4) on 8/14/2018 and is pending investigation.

• Brand Name: DERMAFLOAT LAL SYSTEM
• Type of Device: PATIENT AIR MATTRESS
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 97499 ; MX 97499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 97499 ; MX 97499
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 7812468
• MDR Text Key: 118106461
• Report Number: 3009402404-2018-00054
• 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: company representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/23/2018

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: DFLAL-3680-M
• Device Catalogue Number: DFLAL-3680-M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Manufacturer Received: 07/24/2018
• Initial Date FDA Received: 08/24/2018
• 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: 74 YR
• Patient Weight: 72