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

Model Number DFLAL-3680-M

Device Problem Unintended Deflation (4061)

Patient Problem Abrasion (1689)

Event Date 08/29/2020

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user, per facility, the patient is on a 36 x 80 dermafloat.Not only is it too small, it keeps deflating.A pickup for that mattress (b)(6) and a delivery for a 42" dermafloat (b)(6) were created for stat delivery 8/28.However, the technician marked the item as no inventory and the order was pushed back to 8/29, which has again been pushed back due to no inventory until 8/31.Shortly after the call was made to replace the mattress, the mattress deflated, causing the patient to fall to the floor and become injured.Abrasions slipping out of the bed, patient hit his head.Bandages were applied to cover the wounds.Complaint # (b)(4) and ra# (b)(4) were entered into our system to have the lift returned to joerns for investigation.As of this writing, the lift 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: 10590979
• MDR Text Key: 212360275
• Report Number: 3009402404-2020-00035
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DFLAL-3680-M
• Device Catalogue Number: DFLAL-3680-M
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/31/2020
• 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