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 Fall (1848)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to the manufacturer by the end user, per the end user, per caregiver, patient already had a fall twice while on the mattress.She states that our mattress is working fine and is very comfortable for the patient, however, the side rails provided by apria for their bed frame is the same height as the mattress.She has already reached out to apria to get a set of different side rails, but they had none available.Per caregiver, patient had a fall early this morning, his wife was in the upstairs bedroom and saw him fall through the video monitor.She states that there were no injuries to the patient, but the wife had to call 911/paramedics because she is unable to lift him back up onto the bed.The patient did not sustain any injuries.Complaint (b)(4) was entered into our system.

• 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 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros,, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, tx ; 8260270331
• MDR Report Key: 9803746
• MDR Text Key: 200508683
• Report Number: 3009402404-2020-00018
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DFLAL-3680-M
• Device Catalogue Number: DFLAL-3680-M
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/11/2020
• 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