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

Device Problem Increase in Pressure (1491)

Patient Problem Fall (1848)

Event Date 12/06/2022

Event Type  malfunction  

Manufacturer Narrative

The information obtained is limited, so the investigation is focused on collecting data and clarifying discrepancies (the customer alledged overinflation, however this mattress does not have pump).Investigation is ongoing.Once completed the follow-up will be provided.

Event Description

The customer reported falls from the bed, allegedly due to the mattress being over inflated in the center.There were no specific details provided regarding the falls.This report is submitted taking a conservative approach, solely due to the allegation of falls and not due to the mattress problem.

Manufacturer Narrative

Data are being compiled.The supplemental will be provided, when the investigation conclusion is completed.

Manufacturer Narrative

Please note that code in annex a was selected to show the customer perception, not the actual outcome from the investigation.Atmosair 9000 mattress is a non-electric system, 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.As per the atmosair instruction for use 407391-ah rev 04 when the mattress seems too firm upon arrival, the solution is to apply weight to the mattress to open valves.No issue was found while evaluating a random sample at the manufacturing site.Atmosair instruction for use 407391-ah rev 04 warns: ¿use or non-use of restrains, including side rails, can be critical to patient safety.Serious or fatal injury can result from the use (potential entrapment) or non-use (potential patient falls) of side rails or other restraints.¿ it is unknown why the customer reported overinflation.The sat cell are built of foam, this system does not require a pump in order to inflate the cells.The self adjusting technology allows the pressure, to escape through the valves when patient weight is applied.The investigation did not show any link between the alleged overinflation and the patient fall.In summary, the arjo mattress was used during the reported fall and thus played a role in the event, however, the analysis revealed that there is no reason to believe that the mattress could overinflate itself causing a patient fall.The customer allegation was not confirmed.

Manufacturer Narrative

A sampled mattress returned for manufacturer investigation was inspected and no discrepancies were noted.Data gathered are being compiled.When the conclusion from the investigation is availabe a supplemental report will be provided.

• 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: 17011514
• MDR Text Key: 316045524
• Report Number: 3007420694-2023-00113
• Device Sequence Number: 1
• Product Code: IKY
• 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,Followup,Followup
• Report Date: 08/31/2023

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/26/2023
• Supplement Dates Manufacturer Received: 06/20/2023; 06/20/2023; 06/20/2023
• Supplement Dates FDA Received: 07/20/2023; 08/18/2023; 08/31/2023
• Date Device Manufactured: 04/18/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other