MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ATMOSAIR 9000A; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number	AXMRFPU35080TMS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information will be provided upon conclusion of the manufacturer's investigation.
Event or Problem Description
It was reported that a patient fell twice from the mattress.The carer stated there was a "lump" in the mattress.No health consequences were reported.
Additional Manufacturer Narrative
Correction to point d.4 - model number.A customer stated that a patient, who suffers from dementia, fell twice from arjo atmosair 9000a mattress, allegedly because a cell was raised on the mattress surface.One fall occurred in the morning of (b)(6) 2020 and second occurred in the evening of (b)(6) 2020.During bothh falls pump was turn on.No injury was sustained.The patient stated that she wanted to sit on the edge of the bed and fell out of it.According to the customer, the patient is restless at night and sometimes found on the edge of the bed.The customer has their risk prevention protocol including: bed at the lowest position, movement sensor at the foot end of the bed.The two incidents were submitted separately to competent authority under 3007420694-2020-00037 and 3007420694-2020-00038.Mattress and pump was inspected by arjo service technician and no fault was found.A dummy was placed on a mattress connected to the pump.Two scenarios with pump turned on and off were tested, no significant differences were noticed.Photographic evidences provided show one cell that looked slightly raised, which can be explained by an activated pump.When a pump is activated the cell will raise slightly for an alternating therapy.From the provided evidences, it is unknown if the mattress fits the bed frame properly, if patient condition, such as dementia and being restless, could influence the event.Taking all that into account, it is impossible to indicate a cause of patient falls.The pump and mattress were operating properly, no discrepancies could have been identified.When reviewing reportable complaints related to patient falls, only these two complaints (being a subject of this investigation) were found.When the event occurred, arjo mattress was used for a patient treatment and thus played a role in the event, however no failure could have been identified.We report this event, solely due to information about patient fall from arjo mattress.

• Brand Name: ATMOSAIR 9000A
• Common Device Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• MDR Report Key: 9738486
• Report Number: 3007420694-2020-00037
• Device Sequence Number: 1974230
• Product Code: FNM
• UDI-Device Identifier: 05055982784986
• UDI-Public: (01)05055982784986(11)190729
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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
• Operator of Device: Other
• Device Model Number: AXMRFPU35080TMS
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 89 YR
• Patient Weight: 75