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

Model Number DFLAL-3680-M

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Abrasion (1689)

Event Date 09/09/2020

Event Type  Injury  

Event Description

It was reported to the manufacturer, by the end user, per the end user, per spouse states the patient has fallen off the dermafloat on 3 different occasions while attempting to get up off the bed.She states he cannot walk very well and needs assistance getting in and out of bed.She said he refuses to wake anyone for assistance when he needs to get up in the middle of the night.The dermafloat was serviced august 30, 2020 and the cu was exchanged due to patient sinking in the middle.She stated the first incident occurred about a month ago but could not remember the date.The second incident/ fall was on (b)(6) 2020 in the early morning hours.The 3rd incident occurred on wednesday (b)(6) 2020 in the early morning hours and that time he was injured.He had a scratch by his right ear.They did not take him to the emergency room or have a doctor check him out.Complaint # (b)(4) and ra# (b)(4) was entered into our system to have the mattress and control unit returned for investigation.As of this writing, the units have not been returned.

• Brand Name: DERMAFLOAT LAL
• 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: 10688020
• MDR Text Key: 212547318
• Report Number: 3009402404-2020-00038
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/14/2020

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: Lay User/Patient
• Device Model Number: DFLAL-3680-M
• Device Catalogue Number: DFLAL-3680-M
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/15/2020
• 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
• Patient Outcome(s): Other