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

Model Number DFLAL-3680-M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 03/31/2023

Event Type  Injury  

Manufacturer Narrative

This report or other information submitted by joerns healthcare under 21 cfr part 803, and release by the 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.

Event Description

It was reported to the manufacturer, by the end user, per the end user, that i received a call from c stating that she needed the bolster cover for the patient.I looked up the current equipment and noticed that she was supposed to be on the statguard 3lal that was ordered back on (b)(6).I asked if the current matt did not have bolsters and carolyn confirmed that it did not.I then asked if the patient had fallen and carolyn reported that she had indeed but had not suffered any injuries at this time.I placed the service order with the notes "needs the bolster for the mattress too.Patient fall incident all items must be switched out and quarantined at the warehouse until further instruction." the mattress was originally ordered back on 12/30 as a statguard 3 lal with order #4501172019.It appears however that a dermafloat lal was placed with assets j3014428/j1228404.It does not appear that there has been a service order or any kind of request to swap out until now.The mattress is still in use by the patient in room 705 at the facility awaiting swap out.Complaint #(b)(4)and ra #84092125 was entered into our system to have the mattress returned for investigation.As of this writing, the product has 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: 16874055
• MDR Text Key: 314634783
• Report Number: 3009402404-2023-00018
• 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: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 04/04/2023
• 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: Female