Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ATMOSAIR 9000; MATTRESS, FLOTATION THERAPY, NON-POWERED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARJOHUNTLEIGH POLSKA SP. Z O.O. ATMOSAIR 9000; MATTRESS, FLOTATION THERAPY, NON-POWERED Back to Search Results
Model Number A9MRLVG35080TCS
Device Problem Device-Device Incompatibility (2919)
Patient Problem Fall (1848)
Event Date 07/11/2022
Event Type  malfunction  
Manufacturer Narrative
The investigation is in progres.The conclusions will be provided within the follow-up report once the investigation is completed.
 
Event Description
Following the information provided the patient fell off the atmosair 9000 mattress.The mattress was placed on the competitor's umano ook cocoon bed at the time of event and based on the photographic evidence provided, the mattress is not compatible with the bed frame.The mattress does not seem to fit the new frames properly - it is too wide and therefore slopes to the side.No injury was sustained.
 
Manufacturer Narrative
The investigation is in progres.The conclusions will be provided within the follow-up report once the investigation is completed.
 
Event Description
Following the information provided the patient fell off the atmosair 9000 mattress.The mattress was placed on the competitor's umano ook cocoon bed at the time of event and based on the photographic evidence provided, the mattress is not compatible with the bed frame.The mattress does not seem to fit the new frames properly - it is too wide and therefore slopes to the side.No injury was sustained.
 
Manufacturer Narrative
In the course of investigation the arjo representative mentioned also that the customer communicated an additional issue with the mattress involved in this event.It allegedly resulted in creating a bulge in the middle of the mattress.The arjo representative together with the arjo technician visited the customer to inspect the device.The technician released some air from the mattress cells valve to solve the complained symptom.This mattress is a reactive mattress equipped with sat (self-adjusting technology) system with 9 hybrid cells (inflatable, filled with foam) located across.The pressure in the cells adjusts depending on the applied load.It means that the air is moving from one cell to another depending on where the load is placed.The complaint indicated that the patient fell to one site of the mattress, however if the air in one cell would have been stopped, then the slope would be on both sides of the mattress.For this reason, the bulge as a potential cause of the fall have been ruled out.Based on all collected information and analysis of the photographic evidence, it was concluded that the most likely root cause of the patient¿s fall is usage of the atmosair 9000 mattress with an incompatible bed frame.The mattress retainers of the frame are too narrow for this mattress, which did not allow to place the mattress correctly on the frame.As a result the mattress was laid on the top of mattress retainers instead of being between them.It was confirmed that the dimensional issue does not concern arjo atmosair 9000 mattresses, but the umano bed frame.Arjo device failed to meet its performance specification since patient fell out of it.The device was used for a patient treatment when the failure occurred, therefore it was involved in the event.This complaint is deemed reportable due to allegation of patient's fall from the mattress.Please note that previous medwatch reports for this product may have been submitted under the following registration number: 3010048749.Currently, this product is to be submitted under arjohuntleigh polska sp.Z.O.O.Registration number: 3007420694.
 
Event Description
Arjo received two similar customer complaints from the same customer concerning patient falls from atmosair 9000 mattresses.One of the events occurred on (b)(6) 2022 (described below - reported to fda under 3007420694-2022-00130) and the second occurred on (b)(6) 2022 (reported to fda under 3007420694-2022-00131).Following the information provided the customer complained that the mattresses are sloping to one side and residents are rolling into the side rail.In the complained event the patient fell from the mattress as a result.No injury was sustained.Arjo representative contacted and visited the customer in order to establish the details of the complained event.It became apparent that shortly before the incident the customer bought new umano ook cocoon bed frames and decided to use their own atmosair 9000 mattresses with these frames.The photographic evidence and information provided by the customer suggests that the mattress does not fit the bed frame and as a result the mattress is laid on the top of mattress retainers instead of fitting between them.The arjo representative confirmed with the customer that the issue is related with the dimensions of bed mattress retainers and not with arjo mattresses.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key15190694
MDR Text Key304308531
Report Number3007420694-2022-00130
Device Sequence Number1
Product Code IKY
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/08/2022
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 Other
Device Model NumberA9MRLVG35080TCS
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/11/2022
Initial Date FDA Received08/09/2022
Supplement Dates Manufacturer Received07/11/2022
Supplement Dates FDA Received09/08/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
-
-