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

Model Number DFLAL-CU

Device Problem Infusion or Flow Problem (2964)

Patient Problem Fall (1848)

Event Date 02/09/2023

Event Type  Injury  

Event Description

It was reported to the manufacturer, by the end user, per the end user, that (b)(6) called from the facility questioning if we had any kind of mattress that has bolsters or sidewalls on them because they were experiencing an issue with this patient.With a little bit of probing k explained that the patient keeps falling out of the bed.(b)(6) reported that the patient says it is because of the mattress but she mentioned he is on a wound vac and they have him propped up on wedge pillows to keep him on his side so that the wound vac can work.She said that he has a tendency of moving around and then falling out of the mattress after the air "mounts up behind him and makes him feel like the mattress is pushing him out." it appears that the original bari mattress that was requested on our end was for a rt3000b but what was delivered was a dflal-4280nz.I originally placed a service order on the mattress but once i got to thinking about it i realized that it might be dangerous for this patient to end up on a turn matt since he has already had some falls so i put the request in as a pick up and a delivery.(b)(6) did mention that the patient has to be sent to (b)(6) hospital for exams every time he falls due to the fact that the patient is on blood thinners and they must make sure he did not hit his head when he fell and that does not have a brain bleed.So far all i've had reported to me is that he was all banged up.The equipment is still under the patient at the facility awaiting pickup.Assets are j7363524/r205651 and were delivered under order#: (b)(4).I put notes about the patient fall into pick up order#: (b)(4) and then requested a replacement with bolsters under order #: (b)(4).Complaint#: (b)(4) and ra#: 84091645 was entered into our system to have the products 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 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 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: 16572322
• MDR Text Key: 311575369
• Report Number: 3009402404-2023-00008
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DFLAL-CU
• Device Catalogue Number: DFLAL-CU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• 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: Male