MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ATMOSAIR 9000; MATTRESS, FLOTATION THERAPY, NON-POWERED

Device Problem Use of Device Problem (1670)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Event Description

On (b)(6) 2023 arjo became aware of patient, who developed a serious injury while laying on atmosair 9000, which is a hybrid mattress.A patient had stage 2 pressure injury on buttock upon admission which progressed to an unstageable pressure injury.The same facility reported 2 additional serious injuries, which were submitted under importer medwatch numbers 1419652-2023-00010 and 1419652-2023-00011.The investigation, which included an interview with the customer, revealed that several factors may have contributed to the pressure injuries: staff was using the bleach, which may have degraded the cover fabric, the mattress was not checked for wear, the customer's staff did not have protocols in place for moisture and continence reduction; covid changes required changes in hiring new employees who needed education.

• Brand Name: ATMOSAIR 9000
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• MDR Report Key: 16370342
• MDR Text Key: 309461579
• Report Number: 1419652-2023-00012
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2023
• Distributor Facility Aware Date: 01/16/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization