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  

Manufacturer Narrative

The product instructions for use provides guidance, information and recommendation on how to maintain the mattress, including its cleaning and regular verification for wear.The document states "check the mattress surface for tears or cracking; do not use if tears or cracks are present¿.In terms of skin care and patient monitoring, the document states: ¿remove excess moisture and keep skin dry and clean.Check patient¿s skin regularly, particular in areas where incontinence and drainage occur¿.Based on the above, it was determined that pressure injury may have developed as a result of insufficient patient skin monitoring and mattress maintenance.The product assessment, product cleaning and best practice have already been discussed with the customer.The atmosair 9000 was used for a patient treatment when the patient developed a serious injury and was therefore involved in the event.The mattress cover may have failed, however the failure was related to the lack of mattress maintenance, as recommended by the product instruction for use , not the device itself.This event is reportable solely due to indication of a serious injury development while using of the arjo product.

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 developed a pressure injury on the heel which was not present on admission.In 3-4 days the pressure injury on the heel developed into a deep tissue injury (dti).The same facility reported 2 additional serious injuries, which were submitted to fda under the following medwatch numbers 3007420694-2023-00029 and 3007420694-2023-00030.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
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 16370346
• MDR Text Key: 309477227
• Report Number: 3007420694-2023-00031
• 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: Manufacturer
• Source Type: User Facility,Company Representative
• 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
• Date Manufacturer Received: 01/16/2023
• 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): Hospitalization