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 Date 06/08/2022

Event Type  Injury  

Event Description

It was reported to the manufacturer, by the end user, per the end user, that per (b)(6) the nurses were changing patient and there was an accident.The patient fell off of the other side of the bed.(b)(6) did not seem to have a lot of details when i asked if he knew exactly what happened.He just wanted to have us bring the bolsters for the mattress.I put in a service order and requested the items be swapped due to the patient fall.The original delivery was back on (b)(6) 2022 with order #(b)(4).It seems we did a service order back on (b)(6) 2022 with order #(b)(4) because the mattress was deflated in the middle.The current matt and cu (j1585606/ j5989108) is at the facility on the patient's bed awaiting swap out.(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.

Manufacturer Narrative

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

• 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; 2100 design road; arlington TX 76014
• Manufacturer Contact: mackenzie bay ; avenida pedro hinojosa no. 26; cuidad industrial; matamoras, tamaulipas 87499 ; MX 87499
• MDR Report Key: 14982210
• MDR Text Key: 295679766
• Report Number: 3009402404-2022-00016
• 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: 07/09/2022

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: Health Professional
• Device Model Number: TXLAL-3680-M
• Device Catalogue Number: TXLAL-3680-M
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/09/2022
• Initial Date FDA Received: 07/11/2022
• 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