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 Problems Pain (1994); Neck Pain (2433)

Event Date 08/09/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to the manufacturer, by the end user, per the end user, that patient's husband called in stating that the mattress is sinking in the middle and is not staying firm.Poc stated she fell out of the bed approx.05:30am and head was stuck between matt and railing.Pt is complaining of pain neck and poc is applying ice.Poc sleeps besides pt and woke him up screaming and found patient half on and off the bed with head stuck between rail and matt.Complaint #(b)(4) and ra #(b)(4) were 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: 17711691
• MDR Text Key: 322971730
• Report Number: 3009402404-2023-00033
• 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: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• 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: 08/09/2023
• 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