MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP Z O.O ATMOSAIR 9000; IKY

Model Number UNKNOWN

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

Patient Problem Fall (1848)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This appears to be a "malfunction" type of event not because there was an actual technical malfunction of the device (we found no evidence of it), but since the information received could be interpreted as the device not having performed as intended.When reviewing similar reportable events for the device family range, we have been able to establish that this complaint is a single, isolated event.No trend is observed for this failure.Atmosair 9000 is a non-powered pressure redistribution mattress replacement system with self adjusting technology¿.It purpose is to help maximize body weight displacement and minimize tissue interface pressure by automatically adjusting the internal air pressure in reaction to body movements.All devices offered by arjohuntleigh are assembled in accordance with their relevant and current work instructions and checked, before they are cleared for dispatch.The device must be in full working condition before being cleared for dispatch.With the limited information provided we were able to establish that when the event occurred and patient fell from the mattress, the facility was using an arjohuntleigh branded, atmosair 9000 device with unknown bed frame.Unfortunately, since no detailed information regarding serial number were provided, we are unable to trace the manufacturing date of this unit.The facility staff stated that regardless the raised issue, there was no malfunction found in the area of mattress.The root cause of the patient fall could not be established based on the information available.The product user manual (e.G.#407384-ah rev.C) provides detailed instructions for use and caregivers are advised to read all chapters of the manual prior to product use.The manual contains sections designating indications for use, contraindications, precautions and safety tips as well as detailed instructions for use.It is also worth to be noted that in order to ensure safety and compatibility between mattresses and used bed frame, the atmosair series is available in different sizes to accommodate different frames.Bed frame precautions are contained on mattress foot tag and in the user guide.Atmosair 9000 has magnets integrated on the bottom cover to help keep the mattress in place during foot section extension / retraction.Also, a non skid cover options are available to enable mattress slipping off the frame as this situation and incorrect selection of used bed frame could contribute to the patient unintentional exit.In summary, upon the conducted investigation, there is no indication that the mattress in any way malfunctioned, however it was being used at the time of the event for patient treatment, and due to this played a role in the incident.Unfortunately, the exact root cause could not be established.It was decided to report this complaint based on the potential related with patient falling from the device and to be transparent with our current reporting approach.We shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

On (b)(6) 2013 the clinical manager reported multiple instances of residents falling out of the bed while using customer owned atmosair mattresses.On (b)(6) 2014 the regulatory compliance specialist confirmed with the account executive there were no injuries associated with this event and no malfunctions with the mattress.

• Brand Name: ATMOSAIR 9000
• Type of Device: IKY
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5864505
• MDR Text Key: 51935213
• Report Number: 3007420694-2016-00171
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/10/2016,12/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2016
• Distributor Facility Aware Date: 12/23/2013
• Date Report to Manufacturer: 08/10/2016
• Initial Date Manufacturer Received: 12/23/2013
• Initial Date FDA Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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