MAUDE Adverse Event Report: JOERNS HEALTHCARE TXCAIR; PATIENT AIR MATTRESS

Model Number TXVMLAL-3588-M

Device Problems Detachment of Device or Device Component (2907); Component Misassembled (4004)

Patient Problem Blister (4537)

Event Date 08/27/2020

Event Type  Injury  

Event Description

It was reported to the manufacturer, by the end user, per the end user, per wcn, pt has developed a pressure ulcer due to the hose detaching and the matt deflating repeatedly.She states that this resulted quickly as the pt's physical condition and skin is delicate.Complaint #(b)(4) and ra#(b)(4) was entered into our system to have the mattress and control unit returned to joerns for investigation.

• Brand Name: TXCAIR
• Type of Device: PATIENT AIR MATTRESS
• Manufacturer (Section D): JOERNS HEALTHCARE; 1032 north 4th street; baldwyn MS 38824
• Manufacturer (Section G): JOERNS HEALTHCARE; 1032 north 4th street; baldwyn MS 38824
• Manufacturer Contact: mackenzie bay ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 10590987
• MDR Text Key: 208718526
• Report Number: 3009402404-2020-00033
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TXVMLAL-3588-M
• Device Catalogue Number: TXVMLAL-3588-M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/26/2020
• 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
• Patient Age: 63 YR
• Patient Weight: 50