MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ATMOSAIR 9000A; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number AXMRLVG35080TCS

Device Problem Increase in Pressure (1491)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2022

Event Type  malfunction  

Manufacturer Narrative

Currently there is not enough information to provide a conclusion.When the investigation will be completed, the follow-up report will be provided.

Event Description

The customer alleged that the mattress had a "hump" in the middle and sloping to the right.Patient was rolling to rails, no fall, no injuries occurred.

Manufacturer Narrative

Please note that code in annex a was selected to show the customer perception, not the actual outcome from the investigation.The customer alleged that the mattress appeared over-inflated in the center, sloping to the right side.In a result, a patient was rolling to the bed side rails.The event did not result in the fall.No injury was claimed.The customer concern was that the edge is not stable creating a safety risk for resident with mobility issues.Mattress was taken out of use.The system (mattress and the pump) was inspected by an arjo service technician and no fault was found.The product operated properly.Atmosair 9000a mattress is a hybrid mattress, utilizing atmospheric pressure and gravity as the energy source.The self adjusting technology (sat) uses one-way pressure relief valves that allow air to escape when a load is applied.When a pump is used, the system can change from reactive to active mode through alternating therapy.This product is built of sat cells which are placed in the foam shell/cavity.There are 9 cells in the cavity surrounded by the foam, so the edge (rail), the customer was mentioning, most likely refers to the foam that surrounds the sat cells.This is a hybrid mattress which construction is different than the foam mattresses or air mattresses.It is only suspected that the customer¿s perception of the hybrid mattress could be related to its comparison to the foam mattress.Before using the product, the user should familiarize themselves with the product instruction for use.The atmosair 9000a instruction for use (ifu) 407391-ah rev 04, includes the following safety information: - "patient migration - speciality surface have different shear and support characteristics than conventional surfaces and may increase the risk of patient movement, sinking and / or migration into hazardous positions of entrapment and / or inadvertent bed exit." - "caregiver should always aid patient in exiting the bed.[.]".- it is responsible of a care facilities to "follow all applicable safety rules and institution protocols concerning patient and caregiver safety".There was no product failure.It is unknown why the customer reported overinflation and patient rolling to the side, however it is suspected that it could be related with the individual perception, and not with the product problem itself.Another, customer concerns referred to the patient with mobility issues which could fall, however, the product ifu states to aid the patient when exiting the mattress.In summary, the arjo mattress was used when the patinet was rolling to the bed side rails and thus played a role in the complaint.There was no product defect.No overinflation was detected during product inspection.The customer¿s allegation could not be confirmed.There was no fall from the mattress, and when all safety protocol are in place there is not risk of patient falling from the bed.It is the obligation of caregivers to ensure safety of the product usage.Therefore, the complaints were no fall occurs as the customer follows ifu and facilities internal safety protocol are deemed not reportable.

• Brand Name: ATMOSAIR 9000A
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• 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: 17000460
• MDR Text Key: 315917300
• Report Number: 3007420694-2023-00107
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05056341697763
• UDI-Public: (01)05056341697763(11)220311
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AXMRLVG35080TCS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2022
• 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