MAUDE Adverse Event Report: JOERNS HEALTHCARE CAIR 1000; PATIENT AIR MATTRESS

Model Number CREXLAL-CU

Device Problems Infusion or Flow Problem (2964); Pressure Problem (3012)

Patient Problem Pain (1994)

Event Type  malfunction  

Event Description

It was reported to the manufacturer, by the end user, per the end user, that veteran is in serious pain with progressive health issues connected with specialty mattress not being properly inflated.The veteran has been without a serviceable lal mattress since (b)(6) 2023.Complaint #(b)(4) were entered into our system to have the mattress returned for investigation.As of this time, the unit has not been returned.

Manufacturer Narrative

This report or other informtion 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.

• Brand Name: CAIR 1000
• 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: 18757169
• MDR Text Key: 335989445
• Report Number: 3009402404-2024-00002
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CREXLAL-CU
• Device Catalogue Number: CREXLAL-CU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/22/2024
• 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 Sex: Male