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An investigation was carried out into this complaint with the following result.On 25 january 2017 an arjohuntleigh representative reported mattress failure with a (b)(6) lbs patient, that had suffered a deep tissue injury on his sacrum.Based on that statement, a complaint record was opened on 26 january 2017, in our internal complaint handling system.After received this information, the attempts were made to contact the facility on 2 february 2017 to verify if this could be the same patient and incident already reported by the facility on (b)(4) 2017 (mdr 3007420694-2017-00031).The facility could not confirm that, therefore the above complaint was determined reportable as well.On 13 february 2017 the arjohuntleigh representative acknowledged that evolve mattress involved in the incident had serial number (b)(4).According to the arjohuntleigh representative "one of the pods appeared to have holes, no valves appeared to be leaking.The middle pods are weak and are no longer as stiff as the pods on the sides.The mattress was collapsed and the patient was resting on the frame." since 14 february 2017 the attempts were made to identify location of the mattress with serial number (b)(4).Unfortunately, despite the efforts the mattress could not have been located at a service center or at a contract manufacturer wcw site, to whom the mattresses collected from the facility were sent for further evaluation.Additional information provided was that: the mattresses were purchased by the facility in may 2014.Many of the mattresses had covers damaged by cleaning process used by the facility.Mattresses were used on the stryker in touch frame.The facility was using an egg crate foam layer on top of their mattresses.According to an account manager "icu protocol was followed in respect to patient positioning and head of bed angle."these mattresses were handled by the facility as stated in the product manual and instructions for use.The only material between the patients and the mattress is the skin iq and 1 driflo pad." no specific data regarding pre-existing medical patient condition, turning protocol applied or microclimate management was provided.69 evolve mattresses were collected from the facility and sent in three groups: february 2017, march 2017, april 2017, for further evaluation to contract manufacturer wcw.The contract manufacturer wcw was inspecting the returned mattresses from march 2017 till june 2017 and on 11 july 2017, provided a final inspection report.According to the report 52 systems out of 69 did not pass the pressure drop test for various reasons.47 of them had a leak in the harness and in addition in 40 systems, pods were found with a hole in a wall at the last convolution.In 5 instances presence of debris was noticed.In 4 instances these particles prevented the check valve from closing which resulted in a leak.All affected mattresses were from 2nd generation designs with sealant application to the flash on the bellow t-part.Within the returned systems, a contract manufacturer identified four problem areas: holes in pods; leaking harness; check valve leak; harness obstruction.In order to verify if pods (bellows) had been built in accordance to specification, they were sent for evaluation to the external supplier, who concluded that bellows which were reported to have failed in the field, were found to meet the manufacturer specification.Further pod (bellow) inspection revealed that the holes were occurring on the last convolution of the bellow in the center area of the system.A bypass test revealed that the holes in pods were a secondary root cause and leakage along the harness was the primary root cause of the hole.A bellow that fell into voided area of foam, that surrounds harness, could not reform due to unachieved optimal pressure.The inability to reform along with patient movement, most likely attributed to bedframe articulation, resulted in a hole at the lowest convolution.Check valve evaluation identified particles that migrated into the valve.The particles were preventing the check valve from closing resulting in a leak.It was determined that the particles were coming from the grey fabric that encases the system.The above problems have already been addressed by the contract manufacturer, who initiated changes in foam strip width to ensure that the last convolution of the pod is supported by 1 inch deep foam strip rather than ½ inch.A sealant and sealant application, in the production process, became an obsolete.The process was replaced with reaming the excess flash from the pod t-part to eliminate potential leak in the harness.To eliminate the risk of contamination to the check valve by particles a filter to each foot end of the pressure iq evolve system was added in february 2017.Product problems found during wcw evaluation, such as holes in pods, harness leak or check valve leak had been subjected to pressure mapping test performed by arhohuntleigh's r&d department in (b)(4).Test report dated on 20 june 2014, tested evolve mattress in various states of use, i.E.With valves reversed, evolve mattress with 70 g pods subjected to a 180lbs test dummy on a fully articulated bed for over one month, a mattress subjected to 14.600 articulation cycles, a mattress with concavity approximately 3 inches, mattresses returned for inspection from the field with three failure modes: pin holes in pod side wall, valve placed incorrectly, and missing tube connection.A 170 lb dummy was used to test mattress in both supine and cardiac positions.It was concluded that the evolve surface was performing as intended even after subjected to various states of use.The only condition that showed unacceptable performance was when the cover was installed incorrectly in a way that patient is placed on a sat system and not on the foam surface.In october 2016 the arhohuntleigh's r&d department in (b)(4) performed pressure mapping on mattresses with the following conditions: mattress with harness leak, sat valve was removed from the system to determine if the interface pressure would exceed 29.8 mmhg, when all the air was able to exit the sat system.The mattresses were pressure mapped in supine and cardiac position and all met the design requirement for interface pressure of 29.7 mmhg, which would indicate that there was no excessive pressure that could have caused or contributed to a serious injury.The mattress involved in the incident could not have been located and had not been returned to the contract manufacturer wcw for evaluation, thus the initial suggestion provided by the arjohuntleigh representative that one of the pods appeared to have holes and that pods were weaker in the middle section could not have been confirmed.It is worth noting that prevention and management of pressure ulcers is a holistic patient care activity.Nursing management includes a 24-hour individualized repositioning regime, early mobilization, good nutrition, management of incontinence and restricted time spent seated.User manual (#413657 ah rev.C) 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 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 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.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 (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).If all other care is not considered and/or given, a mattress will not, on its own, prevent or treat pressure ulcers.In summary, the mattress involved in the incident could not be located and had not been sent to contract manufacturer for evaluation, therefore it is unknown if the mattress reported by the facility malfunctioned.The mattresses returned from the facility were evaluated by contract manufacturer, who found some of them malfunctioned.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.The performed tests have indicated that, even with cracked pods and in the worst case scenario, where tubing were removed from the mattress, the original interface pressure requirement defined in the rtm (pindex 29.7 mmhg) was met, which might indicate that there was no excessive pressure that could have caused or contributed to a serious injury.The mattress is designed to have greater immersion than other typical foam designed mattresses.This can be an annoyance to the customer when repositioning a patient.By a process of immersion and envelopment, this reactive support surface redistributes the body's mass over a greater surface area.Pressure redistribution is achieved by employing self adjusting technology¿ (sat¿).The internal air pressure of helix pod array automatically adjusts in reaction to a patient's movements, evenly distributing body weight throughout the mattress and displacing pressure away from vulnerable anatomical locations such as heels, sacrum and hips.The foot end of the mattress has a 50 slope to reduce the level of pressure borne by the heels.The mattress is not a substitute for patient monitoring or care, therefore a user error related to such monitoring can contribute to product risk.The 3 inch topper foam is preventing immediate harm to the patient allowing the facility to take action if they are following the standard guidelines set in the "npuap" (national pressure ulcer advisory panel) guidelines and instruction incorporated in the user manual.Basing on the above, it was concluded that a root cause of the patient outcome cannot be identified with certainty.An investigation under corrective and prevention action has been initiated to investigate customer reports in regards to mattress bottoming out taking into account handling the mattress by facilities in order to increase the quality and efficiency of care when using evolve mattresses.It has been established that an evolve mattress was used for patient therapy at the time of the event.It has not been confirmed that the system had malfunctioned, but it did not perform to specification as the patient sustained a deep tissue injury to the sacrum.This complaint has been deemed reportable to the competent authorities due to patient outcome.Should we obtain any information that would change the outcome of our complaint investigation, an update will be sent to the authority at that time.
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