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

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.

• 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: 14399230
• MDR Text Key: 297054606
• Report Number: 3007420694-2022-00065
• 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: 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 Number: A9MRLVG24580TCS
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/16/2022
• Initial Date FDA Received: 05/13/2022
• Supplement Dates Manufacturer Received: 04/16/2022
• Supplement Dates FDA Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 77 KG