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

Model Number A9MRLVG35083TMS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

This medwatch report is submitted under arjohuntleigh polska sp.Zo.O.Establishment name and registration (b)(4).Additional information will be provided when investigation conclusion is available.

Event Description

A patient fell on the floor.The fall was not witnessed, it happened overnight.The patient had small spot on the arm.No defect was found within arjo mattress.Bed side rails were in their low position.

Manufacturer Narrative

The facility's intervention protocol for high risk fall patients is to place side rails in the lowest position and an alarm device is placed near the bed, which alerts caregivers about patient exiting the bed.In the complaint the caregivers reacted on an "alarm".The patient had small spot on his arm after the fall.When conclusions from the investigation are available, a final report will be provided.

Manufacturer Narrative

Arjo was informed about 4 patients falls from arjo atmosair 9000 mattress (medwatch reports numbers 3007420694-2019-00175, 3007420694-2019-00176, 3007420694-2019-00177, 3007420694-2019-00178).Incidents occurred at a healthcare facility located in netherlands taking care of elderly people with dementia.A patient was found on the floor with a blanket on him.The patient sustained a small spot on his arm.The fall occurred at night, therefore was not witnessed.This patient has had a history of falls and caregivers have been aware of the risk.Following the customer fall risk protocol, the bed frame used (stiegelmeyer model bett elvido-vano, type 188222) was placed at the lowest position with side rails lowered.Additionally, an alarm device was placed near the bed to alert caregivers in case patients exit the bed.In the investigated event, the customer staff reacted on the alarm when patient exited the bed.An arjo atmosair 9000 mattress was inspected by arjo representative who did not find a fault.From the above, it can be concluded that the patient's fall from the bed was most likely related to his medical state and not to atmosair 9000 mattress.Atmosair 9000 user manual states: "side rails and restraints - warning: use or non-use of restraints, including side rails, can be critical to patient safety.Serious or fatal injury can result from the use (potential entrapment) or nonuse (potential patient falls) of side rails or other restraints." "side rails / patient restraints - whether and how to use side rails or restraints is a decision that should be based on each patient's needs and should be made by the patient and the patient's family, physician and caregivers, with facility protocols in mind.Caregivers should assess risks and benefits of side rail / restraint use (including entrapment and patient falls from bed) in conjunction with individual patient needs, and should discuss use or non-use with patient and / or family.Consider not only the clinical and other needs of the patient but also the risks of fatal or serious injury from falling out of bed and from patient entrapment in or around the side rails, restraints or other accessories." to sum up, arjo mattress was used for patient treatment during the reported fall and therefore played role in the event, but did not failed to meet its specification (there was no product failure).The patient fall was most likely related to his medical state.We report this event due to patient fall from arjo mattress.

• Brand Name: ATMOSAIR 9000
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 9237375
• MDR Text Key: 198867795
• Report Number: 3007420694-2019-00175
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2019

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: A9MRLVG35083TMS
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 10/02/2019; 10/02/2019
• Supplement Dates FDA Received: 11/22/2019; 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Weight: 57