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 Pressure Sores (2326)

Event Date 05/04/2023

Event Type  malfunction  

Event Description

The customer reported that they found the resident half out of mattress.The care staff noted a wound to the resident right outer thigh and suspected it occurred from sliding out of bed and hitting part of the bed frame.Later it was clarified that the wound was a stage ii pressure injury (not serious).The mattress allegedly appeared over-inflated.The pressure in the mattress sat system was adjusted.

Manufacturer Narrative

The investigation is ongoing.Results of the analysis will be provided to the follow-up report.

Manufacturer Narrative

Please note that code in annex a was selected to show the customer perception, not the actual outcome from the investigation.Customer reported that two patients fell from the same atmosair 9000 mattress.One patient fell 3 different times.The 3 falls were submitted under individual medwatch report numbers 3007420694-2023-00115, 3007420694-2023-00117 and 3007420694-2023-00119.This report refers to the second patient and fall submitted under medwatch report numbers 3007420694-2023-00122.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.The valves were working correctly, and the technician who decided to adjust the pressure did not indicate any valve blockage.Also, when a random sample was returned for manufacturer inspection, no overinflation was detected, the product operated properly.According to the gathered information, this mattress was used on the non-arjo bed frame- umano ook cocoon.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.¿ 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.The use or non-use of side rails may potentially lead to 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.H3 other text : random sample inspected.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17036231
• MDR Text Key: 316295394
• Report Number: 3007420694-2023-00122
• Device Sequence Number: 1
• Product Code: IKY
• UDI-Device Identifier: 05056341697589
• UDI-Public: (01)05056341697589(11)220421
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: A9MRLVG35080TCS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 06/20/2023
• Supplement Dates FDA Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2022
• 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
• Patient Sex: Female