MAUDE Adverse Event Report: JOERNS HEALTHCARE PROCAIR VR MATTRESS; PATIENT FOAM MATTRESS

Model Number	253-3680
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to the manufacturer, by the end user, per the end user, that complaint from (b)(6) with procair vr foam mattress on top stating this- "patient states that with his back problems that bar is causing him discomfort, and he is unable to sleep well." (b)(6) requested to process a replacement order to replace the faulty procair vr mattress with a txcair plus lal mattress system, that was just purchased on (b)(6) 2025." complaint #(b)(4) and ra #(b)(4) were entered into our facility to have the mattress returned for investigation.As of this writing, the units have not been returned.
Additional Manufacturer Narrative
This report or other informtion 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: PROCAIR VR MATTRESS
• Common Device Name: PATIENT FOAM MATTRESS
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no. 26; ciudad industrial; matamoras, tamaulipas 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no. 26; ciudad industrial; matamoras, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: mackenzie bsy ; avenida pedro hinojosa no. 26; ciudad industrial; matamoras, tamaulipas 87499 ; MX 87499
• MDR Report Key: 22974726
• Report Number: 3009402404-2025-00042
• Device Sequence Number: 9370287
• Product Code: IKY
• UDI-Device Identifier: 00810055883912
• UDI-Public: 00810055883912
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 253-3680
• Device Catalogue Number: 253-3680
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male