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

Model Number A9MSOVG35080NMS

Device Problems Material Discolored (1170); Fluid/Blood Leak (1250); Material Deformation (2976)

Patient Problems Pain (1994); Injury (2348)

Event Date 01/02/2018

Event Type  malfunction  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted for the manufacturing site kinetics concept inc (under registration# 1625774).From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc.And any medwatch reports were submitted under registration #3009988881.From november 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration #3007420694.Additional information will be provided upon conclusion of the investigation.

Event Description

On 2018-jan-02 arjohuntleigh was notified about the complaint involving atmosair 9000 mattress.Following the information reported, the mattress cover had been damaged resulting in fluid ingress to the foam, which became depressed.A patient developed purple marks and felt pain.

Manufacturer Narrative

On (b)(6) 2018 arjohuntleigh was notified about an event with atmosair 9000.It was reported by the customer the her mother had developed purple marks and sustained a pain.The allegation was that the mattress cover had been damaged in waist area and fluid penetrated the top foam layer compromising it and resulting in mattress depression.When reviewing reportable complaints for similar issue we have found some which concern fluid penetrating the foam due to damaged cover, but only one indicates that fluid ingress compromised the top foam layer leaving top foam layer depressed and patient sustaining an injury.Information regarding patient's medical condition, stage of pressure injury, cleaning solutions and protocol used, were not provided by the customer.Based on the information collected to date, provided problem description and photographic evidence we have been able to confirm that the atmosair 9000 mattress cover has obvious signs of wear, top foam layer soiled and slightly concave.The mattress inspection of self adjusting technology¿ (sat¿) of dynamic pressure redistribution air system confirmed that the system was working properly.No defects were detected.The mattress is built of foam top layer and sat cells built of foam, thus there is no possibility of mattress deflation or bottoming out.It is worth noting that foam contains antimicrobial agent thus the possibility of an injury due to foam contamination is also mitigated.When following recommendation given in product instruction for use (ifu) any hazardous situation is unlikely to occur.Ifu 407384-ah rev.B dated on august 2014 includes safety information, warnings and precautions.It indicates to: "monitor skin condition regularly and consider adjunct or alternative therapies for high acuity patients.Give extra attention to any possible pressure points and locations where moisture or incontinence may occur or collect.Early intervention may be essential to preventing skin breakdown", "do not clean with solvents or alcohol", "for regular cleaning use a mild detergent with water on a non-abrasive cloth" "wipe and rinse surface" "[.] using a clean cloth, wring out excess solution until cloth is damp", "allow to air dry", "the cover should be wiped daily with a mild soap and water solution", "check mattress surface for tears or cracking; do not use if tears or cracks are present" "ensure mattress is free of stains and is not overly faded".Please note that, durability of the atmosair products has been verified and the requirements were gathered in manufacturer's design files.It was specified that the product life cycle shall withstand 5 years.This engineering requirements are made based on the cornell and hexagonal roller testing, which mattress durability is checked through 50.000 cycles (it was assumed that 10.000 = 1 year of device life).It may happen that the product life will be reduced depending on its usage.The reported mattress was almost four years old at the time the event was reported.With the limited information provided it was impossible to indicated the root cause of the cover failure and the reason for patient injury.Despite our best efforts and multiple attempts, information regarding circumstances of the event was not released by the customer.Additional information received from the caregivers was that the patient was placed in hospital, sometime after the reported issue, for unrelated reason.It is unknown if the reported injury was related to the patient's pre-existing medical condition.The device was being used for patient handling at the time of the event and in that way played a role in the event outcome.The mattress failed to meet its performance specification as cover had visible signs of wear and foam was stained.We report this incident in abundance of caution due to the allegation of an injury and limited information provided.

• 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, P; PL 62-052, PL
• MDR Report Key: 7220998
• MDR Text Key: 98578531
• Report Number: 3007420694-2018-00019
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

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: Other Caregivers
• Device Model Number: A9MSOVG35080NMS
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/02/2018
• Initial Date FDA Received: 01/26/2018
• Supplement Dates Manufacturer Received: 01/02/2018
• Supplement Dates FDA Received: 02/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other