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

Model Number DFLAL-4280-M

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

Patient Problem Localized Skin Lesion (4542)

Event Date 02/22/2022

Event Type  Injury  

Event Description

It was reported to the manufacturer, by the end user, per the end user, that mr.Wilson called in to request an exchange of the mattress due to the fact that the patient needed a bariatric mattress with bolsters.When i looked up the mattress i noticed it was already a 42x80 so i did a little prompting to find out what the issue was.Apparently the patient keeps falling out of the mattress due to it not being big enough.Mrs.Wilson mentioned in passing that one of the nurses even witnessed it that he would get to the edge and flip out of bed without even realizing it.The facility moved the patient to a regular mattress but they need him on a low air loss mattress due to the skin breakdown he has.The equipment is located at the facility in rm 338 currently awaiting pick up.The dermafloat lal is a 42x80 and the assets are j2882280 and j1807293.Complaint #(b)(4) were entered into our system to have the products returned for investigation.At this time, the units have not been returned.

• Brand Name: DERMAFLOAT
• Type of Device: PATIENT AIR MATTRESS
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no. 26; cuidad industrial; matamoras, tamaulipas 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no. 26; cuidad industrial; matamoras, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: mackenzie bay ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 13896789
• MDR Text Key: 293155802
• Report Number: 3009402404-2022-00004
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DFLAL-4280-M
• Device Catalogue Number: DFLAL-4280-M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2022
• 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 Outcome(s): Other
• Patient Sex: Male