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

Model Number DFLAL-4280-M

Device Problem No Pressure (2994)

Patient Problems Fall (1848); Skin Inflammation/ Irritation (4545); Contact Dermatitis (4546)

Event Date 03/05/2022

Event Type  Injury  

Event Description

It was reported to the manufacturer, by the end user, per the end user, that tech came out on 3/4 and replaced lal but the equipment he replaced it with was not secured and did not fully inflate and she kept hearing noises and the bed eventually collapsed on her.On 3/5 the lal sunk completely into the bed and she could not get her legs out of the bed.When she did she fell out of the bed.She has now broken out into hives and is using calamine lotion.Complaint # (b)(4) and (b)(4) was entered into our system to have the mattress and control unit returned for investigation.As of this writing, the products have not been returned.

Manufacturer Narrative

This report or other information submitted by joerns healthcare under 21 cfr part 803, and any release by fda of that report information, does not reflect a conclusion or admission by joerns healthcare, its employees, its contract service firms, or their employees, finished device suppliers, or their employees caused or contributed to the reportable event.

• 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: 14048784
• MDR Text Key: 293168756
• Report Number: 3009402404-2022-00005
• 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: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DFLAL-4280-M
• Device Catalogue Number: DFLAL-4280-M
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/07/2022
• 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: Female