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

Model Number AXKRLNB39080TES

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

Patient Problems Tissue Damage (2104); Pressure Sores (2326)

Event Date 07/20/2017

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted for the manufacturing site.From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc.And any medwatch reports were submitted (b)(4).From november 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted under (b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

A customer reported that a patient had developed pressure damage to heels, sacrum and spine while on atmosair 9000a mattress.It was identified that the patient had category 1 pressure ulcer to spine, potential deep tissue injury to sacrum and potential deep tissue injury to left heel.Patient mobility described as: "bedbound and unable to reposition herself.Patient was being turned 2 hourly by ward staff." patient treatment included: "repositioning, heel elevation with pillows, nursed on autologic mattress." preliminary evaluation did not reveal faults that could be directly associated with the complaint.Further evaluation is anticipated.

Manufacturer Narrative

An investigation was carried out into this complaint with the following result.Arjohuntleigh was informed about a patient (female, > age 75 years old), who developed pressure ulceration to the heels, sacrum and spine while using an atmosair 9000a mattress during an evaluation period.The patient was placed on the atmosair 9000a mattress on monday (17th july).On tuesday (18th july ) marking was noted to the patient and hence the customer activated the pump for alternating therapy, elevated the heel using pillows and also knee section of the bed was raised.On friday (21st july) the patient developed pressure ulcers.On (b)(6) the customer informed an arjohuntleigh representative that the pressure ulcer were categorized as stage ii pressure ulcer to the sacrum, with potential deep tissue injury to the heel and redness to spine.The patient weight was described as "medium size for her age group" with medium level of risk for pressure ulceration.Before being placed onto the atmosair 9000a, the patient was using an arjohuntleigh auto logic active (alternating) mattress replacement system.No medical history and no information regarding the reason for hospital admission was provided to arjohuntleigh.It was stated, however that the patient's skin condition was intact prior to her transfer to the atmosair 9000a surface.The patient was described as being bedbound and unable to reposition herself, but according to nursing staff , the patient was being turned 2 hourly prior to and after skin damage.Further treatment provided included repositioning and the patient being placed back onto an auto logic mattress replacement system.On (b)(6) 2017 it was reported that the pressure damage this patient experienced was: category 1 to spine, potential deep tissue injury to the sacrum and potential deep tissue injury to the heel.It was confirmed that the category 1 pressure ulcer healed, and potential deep tissue injury to the sacrum and the left heel appeared to be receding and the skin had turned red in colour.When reviewing reportable events for the atmosair product range, we have observed no trend with the allegation of patient developing pressure injury, we have not observed also one leading scenario that could lead to this outcome.The atmosair 9000 model a mattress is constructed with nine horizontally aligned air cells located under the shoulder, torso and seating area.These cells utilize self adjusting technology¿ (sat¿), for pressure redistribution.They are a non-powered pressurized system of independent, dynamic air cylinders with intake and regulator valves.The system responds to patients' weight and movements adjusting and regulating the internal air pressures for consistent pressure redistribution.There is also an option to use a pump which provides active (alternating) therapy.Sat cells are built of an inner foam core, which provides additional support to patients.An upper layer of foam has an 'egg crate'.The foot section is sloped to reduce the load (pressure) applied to the patient's heels.The product serial number that was involved in the incident could not be identified.It is unknown which products were in use with which patients.But it has been stated that the ward uses a mixture of electric bedframes including arjohuntleigh contoura 360 bedframes.After the event, the mattresses and pumps from the evaluation period were removed from the facility and tested.No issues were found during the mattresses evaluation.With the pump attached to the mattress, pressures were also tested.In one case a low pressure setting on port 2 showed 3 mmhg below the required lower limit tolerance specification, the second pump high pressure was 6 mmhg on port 1 and 2 mmhg on port 2 above the upper limit tolerance specification.A heel area of a mattress is made of foam only and has no sat system, therefore no pump impact is possible in that area.Also, even if a pump provides 6 mmhg higher pressure than the required tolerance specification, the valves will compensate for that by venting the excess pressure out of the system anytime a patient weight compresses the sat cells.No failure has been found within a mattress and it was confirmed that the valves were working correctly, therefore these small differences in cell pressures are highly unlikely to have any significant effect on patient outcome or mattress being hard therefore causing patient slippage down the bed.Taking the above into account, it can be emphasized that the atmosair 9000a with the pump or without the pump did not fail to meet its specification.A product malfunction as a potential root cause can be excluded.The impression of the mattress being hard therefore causing the patient to slip down the bed could not be confirmed.The patient impression while laying on a foam mattress in comparison to an air mattress can be different.Before and during the evaluation the customer had been provided with full product training on (b)(6) 2017 with 7 ward staff in attendance.It is unknown, however, if those attendees were providing care to the patient who developed the deep tissue injuries.As a part of training the customer staff were made aware that the mattress foot section has a slope and that there is no self adjusting technology (sat) in this area.They were also advised to use the knee gatch where appropriate to assist with pressure redistribution.Further, it was advised that markings on heels would not be resolved by use of the pump and that the staff would need to combine repositioning and off-loading to heels or put the patient back on dynamic alternating mattress such as the auto logic.From (b)(6) 2017 till (b)(6) 2017 an arjohuntleigh representative visited the facility daily.During this period, a ward sister commented that the heels were marking on a patient, advice was given to offload the heels and to use the knee gatch.No further information was given.No other issues with the mattresses were voiced by the customer staff until the reported incident on the 21st.The customer stated that their expectation was that the atmosair 9000a would replace the auto logic active (alternating) surface and that it would provide the same level of pressure redistribution.It was expressed by arjohuntleigh representatives that an active (alternating) surface like the auto logic cannot be replaced by the hybrid surface as the degree of pressure offloading is greater.For this reason the customer expectation to replace auto logic with hybrid mattresses had been a misconception.Please note that, for patients at higher risk of pressure ulcer development when frequent manual repositioning is not possible, an active support surface (overlay or mattress) is to be considered.A high specification reactive foam mattress is recommended for all individuals assessed as being at risk for pressure ulcer development rather than a non-high specification reactive foam mattress (as per national pressure ulcer advisory panel, european pressure ulcer advisory panel and pan pacific pressure injury alliance.Prevention and treatment of pressure ulcers: quick reference guide.2014).User manual (#407384_ah rev d) provided with each device includes information on how to perform proper skin care while a patient is on the mattress.It also informs the user about the necessity to monitor skin conditions regularly and to consider adjunct or alternative therapies for high acuity patients.Clinicians need to consider a patient's medical condition, individual patient needs and select an appropriate support surface.A mattress will not, on its own, prevent or treat pressure ulcers, therefore all other care is to be considered and given taking into account individual patient needs, such as individualized repositioning regime, early mobilization, good nutrition, management of incontinence and restricted time spent seated.In summary, it is unknown which hybrid mattress was used with the patient who reportedly developed deep tissue injury.The mattresses and pumps, which had been returned from the facility were evaluated by an arjohuntleigh technician, who found them in working condition, no malfunction that might result in patient outcome was found.A mattress surface without the other interventions is insufficient to prevent pressure damage.Frequent positioning of the patient and the type of the support surface chosen for individual needs are both important factors employed in the prevention of pressure ulcers.It has been established that an atmosair 9000a mattress was used for patient therapy at the time of the event.It has not been confirmed that the system had malfunctioned (did not perform to specification) as the serial number of the mattress could not be identified, but the patient sustained deep tissue injuries to the sacrum and left heel and a category i pressure ulcer to the spine and for this reason this event has been deemed reportable to the competent authorities.- attachment: [cover letter.Pdf].

• Brand Name: ATMOSAIR 9000A
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• 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: 6766533
• MDR Text Key: 81795391
• Report Number: 3007420694-2017-00168
• Device Sequence Number: 1
• Product Code: FNM
• 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: 08/30/2017

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: Nurse
• Device Model Number: AXKRLNB39080TES
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2017
• Initial Date FDA Received: 08/04/2017
• Supplement Dates Manufacturer Received: 08/15/2017
• Supplement Dates FDA Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR