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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

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ARJOHUNTLEIGH POLSKA SP. Z O.O. ATMOSAIR 9000; MATTRESS, FLOTATION THERAPY, NON-POWERED Back to Search Results
Model Number A9MRLVG24580TCS
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Fall (1848)
Event Date 04/12/2022
Event Type  malfunction  
Manufacturer Narrative
The investigation is in progress.The conclusions will be provided within follow up report once the investigation is completed.
 
Event Description
Following the information provided the patient fell from the atmosair 9000 mattress, which was placed on arjo minuet bed.At the time of event the bed backrest was raised, the patient slid down the mattress and fell on the floor.No injury was sustained.The mattress was inspected and no malfunction was identified.
 
Event Description
Following the information provided the patient fell from the atmosair 9000 mattress, which was placed on arjo minuet bed.At the time of event the bed backrest was raised, also the egress assist side rail of the bed was raised.The patient slid down the mattress and fell down to the floor.No injury was sustained.The patient was picked up off the floor with a maxi move floor lift and put back to bed.The mattress was inspected and no malfunction was identified.The arjo representative recommended the customer to use higher side rails and raise knee section when the backrest is raised.
 
Manufacturer Narrative
Based on the recommendation provided to the customer it seems most likely that when the bed backrest was raised, the knee section was flat.The instructions for use for atmosair 9000 (407391-ah) includes the following information related to patient falls: - "patient migration - specialty surfaces 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." - "head of bed elevation - keep head of bed as low as possible to help prevent patient migration." the root cause of the complained scenario cannot be defined.The device was evaluated after the event and no malfunction was found.It is unknown what was the backrest elevation angle used and why the patient slid down the mattress.It is unknown whether there was anything on the mattress that could reduce friction between the patient's body and mattress surface (e.G.Patient's clothing material or sheets).Arjo device was used for a patient treatment when the event occurred and from that perspective it played a role in the event.No malfunction was found during the device evaluation.This complaint is deemed reportable due to patient's fall from the device.
 
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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 Key14399230
MDR Text Key297054606
Report Number3007420694-2022-00065
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 Administrator/Supervisor
Type of Report Initial,Followup
Report Date 06/10/2022
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 Lay User/Patient
Device Model NumberA9MRLVG24580TCS
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/16/2022
Initial Date FDA Received05/13/2022
Supplement Dates Manufacturer Received04/16/2022
Supplement Dates FDA Received06/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/04/2022
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;
Patient SexMale
Patient Weight77 KG
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