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

Model Number TXLAL-3680-M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

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 facility alled in to request a replacement mattress with bolsters due to a patient fall.I asked facility if the patient had been injured in the fall but unfortunately she did not have any details.She said that if we needed more information we would need to call back and speak to another facility contact as he would be the one that would have details of the fall and patient status.Patient was on a txcair that was delivered back on (b)(6) 2022 with order #(b)(4).Assets for the equipment are: j1884654/j7411901 and they have been swapped out with assets j3946045/j7419384 per the service order that i created.I put in service order #(b)(4) with notes: "patient fall incident all items must be switched out and quarantined at the warehouse until further instruction" so they should be in quarantine in the wh.Complaint #(b)(4) and ra #(b)(4) was 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: TXCAIR
• 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: 16025344
• MDR Text Key: 305919243
• Report Number: 3009402404-2022-00039
• 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: 12/21/2022

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: Lay User/Patient
• Device Model Number: TXLAL-3680-M
• Device Catalogue Number: TXLAL-3680-M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 12/21/2022
• 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