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

(b)(4).Additional information will be provided when investigation conclusion is available.

Event Description

A patient fell to the floor.The fall was not witnessed, it happened overnight.As a result patient sustained small wound on his elbow.Small band aid was enough.Pain in his head, some slime came up, doctor called.Next morning headache and nauseous, but felt better in the afternoon.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.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 elder people living with dementia.A patient fell on the floor at night.The fall was not witnessed.The patient sustained the small wound on the elbow and head pain /nausea.A small band aid was applied.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 the an alarm device was placed near the bed, to alert caregivers in case patient exit the bed.In the investigated event, the alarm was activated.There was no arjo product failure, but mattress was noticed not fitting to the bed frame properly.Product user manual states the atmosair mattresses needs to be compatible with specific frames: "always use a standard healthcare bed frame with this mattress, with any safeguards or protocols that may be appropriate.Bed frame and side rails (if used) must be properly sized relative to the mattress to help minimize any gaps that might entrap a patient's head or body.It is recommended that bed and side rails (if used) comply with all applicable regulations and protocols." "when selecting a standard mattress, ensure the distance between top of side rails (if used) and top of mattress (without compression) is at least 8.66 in (220 mm) to help prevent inadvertent bed exit or falls.Consider individual patient size, position (relative to the top of the side rail) and patient condition in assessing fall risk." atmosair family has multiple sizes available, which can be configured for different frames.The fall was not witnessed, thus it is unknown if the patient's fall could be related to his medical state or to mattress not fitting the bed frame properly.But because caregivers implemented fall risk intervention protocol, it can be assumed that the patient was classified as a high risk fall patient.From the above it can be stated that the patient's fall from the bed was most likely related to his medical state and not to atmosair 9000 mattress.To sum up, the arjo mattress was used during the reported fall and thus played role in the event, no product failure was found.It is unknown if the patient's fall could be related to his medical state or to mattress not fitting the bed frame properly.

• 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: 9237376
• MDR Text Key: 198868522
• Report Number: 3007420694-2019-00178
• 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: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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; 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 97