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

Model Number DFLAL-3680-M

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

Patient Problem Skin Erosion (2075)

Event Date 05/28/2020

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user, that patient states that due to the lack of the alternating pressure function, she had developed a pressure ulcer which was exacerbated by a secondary condition.She was treated at (b)(6) hospital - (b)(6) on (b)(6) 2020.Pt reports that 5/08/2020 kaiser order was for a dfapl and that the cu was not available so it was subbed for a txcair plus cu.Pt states that she has been trying to get the proper cu delivered and placed multiple calls and messages but had not received any calls back regarding status of cu.Created service order # (b)(4) to swap out equipment, however, no dfapl units are available at this time.Footnote: when pt called on different occasions she was informed that we still did not have the inventory and once inventory of a dfapl was available we would call her to make arrangements to swap out the unit complaint (b)(4) was entered into our system to have the mattress returned to joerns for investigation.As of this writing, the mattress has not been returned.

• Brand Name: DERMAFLOAT LAL
• Type of Device: PATIENT AIR MATTRESS
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas, mx
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas, mx
• Manufacturer Contact: mackenzie bay ; 2100 design road; arlington, tx ; 8260270316
• MDR Report Key: 10328439
• MDR Text Key: 200495448
• Report Number: 3009402404-2020-00026
• 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: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• 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
• Date Manufacturer Received: 05/28/2020
• 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): Hospitalization