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

Model Number 999-3322

Device Problem Deflation Problem (1149)

Patient Problem Ulcer (2274)

Event Date 07/06/2023

Event Type  Injury  

Event Description

It was reported to the manufacturer, by the end user, per the end user, that received a call from wound care nurse from (b)(6) medical center, on 7/6/2023 around 3:30pm.She said that a patient developed a deep tissue injury on the sacral area due to he therapy surface bottoming out.Asked her if the blower was turned on and if there were any alarms.She said that the blower had power and that there were no alarms.Complaint #(b)(4) was entered into our system.

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: ARISE 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: 18192609
• MDR Text Key: 328811037
• Report Number: 3009402404-2023-00042
• 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: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 999-3322
• Device Catalogue Number: 999-3322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• 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