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

Model Number DFLAL-3680-M

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Abrasion (1689)

Event Date 09/01/2020

Event Type  Injury  

Event Description

It was reported to the manufacturer, by the end user, per the end user, per facility that received a request from kaiser today 9/2 to install full rails on bed frame because pt is a fall risk.Two sets of half rails were installed no later than 8/28.Called and spoke to sable/ pt.Dtr.On 9/2 re; request.I explained to sable that our frames do not come with full rails only the two sets of halfs rails which the pt received.She explained that the pt has dementia and was able to maneuver herself in such a way that she fell out of bed between the two rails last night and got her head and hand caught.Bed was in its lowest position.She is concerned this is not the right equipment for her mom and would like a bed with full rails.I informed her that that is something to discuss between the her, the doctor and dme.Told her i would need to make arrangements to switch out equipment but have not been able to do so because she wants to discuss other options with the doctor first.Patient sustained an abrasion on face from getting caught in the rail.Nurse came to visit found that was only thing.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: 10688023
• MDR Text Key: 212487503
• Report Number: 3009402404-2020-00036
• 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
• Type of Report: Initial
• Report Date: 10/02/2020

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: No Information
• Device Model Number: DFLAL-3680-M
• Device Catalogue Number: DFLAL-3680-M
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/02/2020
• 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