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

Model Number A9MRLVG35080TCS

Device Problem Increase in Pressure (1491)

Patient Problem Fall (1848)

Event Type  malfunction  

Manufacturer Narrative

Initial evaluation of the s.A.T system presented some slight over inflation.The tubing was unplugged and the pressure released.After that, the system has equalized and no bulging effect was seen.Conclusions to the reported issues are not yet available.As soon as the investigation will be completed, the follow-up report will be provided.

Event Description

Arjo was notified about patients falls from the mattress.There were 20 falls reported.The customer stated that patients were sliding off the edge of the bed when exiting or transferring and this resulted in a fall.The customer allegation refers to the sensation of cells being firmer that the edging foam.Each of the falls are submitted under separate medwatch report numbers: 3007420694-2022-00210, 3007420694-2022-00211, 3007420694-2022-00212, 3007420694-2022-00213, 3007420694-2022-00214, 3007420694-2022-00215, 3007420694-2022-00216, 3007420694-2022-00217, 3007420694-2022-00218, 3007420694-2022-00219, 3007420694-2022-00220, 3007420694-2022-00221, 3007420694-2022-00222, 3007420694-2022-00223, 3007420694-2022-00224, 3007420694-2022-00226, 3007420694-2022-00227, 3007420694-2022-00228, 3007420694-2022-00229.

Manufacturer Narrative

The investigation is still in progress since the cause of the falls has not been identified.The initial evaluation did not lead to any conclusion.Further, the photos and specifications of the sat system and the foam were reviewed.The system tubings and the foam are correctly rooted and correct size.No issues have been discovered that would lead to the cause of the falls.

Manufacturer Narrative

The customer allegation was thoroughly investigated.A sampled mattresses were first inspected by the service technician.The technician unplugged the valve to release the pressure, then left the mattress overnight.No overinflation, bulging effect or firmness was noticed.The technician also tested the mattress by lying on it.No abnormal mattress behaviour was detected.Then the specification was reviewed and compared with the measurement of the system and foam (which was performed by the technician).It did not reveal any anomalies as well.The mattress was up to the specification.It was decided then to check the random mattress at the manufacturing site.On 20 june a mattress was inspected and again the results were that the mattress was not showing any overinflation or firmness, the tubing was exhausting the air as it should, and the sat cell shrunk and expanded as it should.When pushed down, it returned to its previous size.The mattress was left unused for 24h and no overinflation occurred.The mattress was also stable when the volunteers were laying or trying to leave the mattress.The customer¿s allegation could not be confirmed.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.Sat cells 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.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.The investigation did not reveal any product malfunction and did not show any link between the alleged firmness of the cells and the patient¿s falls.According to the gathered information, the mattresses could be used on the non-arjo bed frame- umano ook cocoon.The customer stated that these frames were received the same day as the mattresses.The photographic evidence provided shows that this bed frame does not have the side rails that would be located in the middle of the bed.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.¿ the use or non-use of side rails may potentially lead to the patient¿s fall.The customer also stated during the meeting with arjo representative, that they are not certain whether the falls were caused by the mattresses.Based on all the evidence collected, arjo was not able to identify the cause of the alleged patients falling from the mattresses.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 lead itself to a patient fall.The customer allegation was not confirmed.

• 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: 16032433
• MDR Text Key: 308278466
• Report Number: 3007420694-2022-00225
• Device Sequence Number: 1
• Product Code: IKY
• UDI-Device Identifier: 05056341697589
• UDI-Public: (01)05056341697589(11)211122
• 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
• Report Date: 07/18/2023

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
• Device Model Number: A9MRLVG35080TCS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 02/02/2023; 06/20/2023
• Supplement Dates FDA Received: 02/27/2023; 07/18/2023
• Date Device Manufactured: 04/13/2022
• 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