|
(b)(4).Initially, it was reported that the evolve mattress did not meet depression specification.During gathering additional information, an email was received which included information about patient's death.From the additional information received we have learnt that the customer allegation was that the mattress did not meet the acceptable limits of 2.5 inch.The mattress indentation was measured by the customer which reported 2.7 inch depression.The customer stated that the patient complained of discomfort and his condition deteriorate while using the mattress.In order to try alternative treatment the patient was moved to the other surface.Soon after was sent to the hospital where passed away.One of the customer statement was that the mattress failure could have contributed to patient's death, however another information received was that the facility actually has not been considering evolve as the cause of the patient decline.The complaint from the resident was of discomfort on the surface.The evolve mattress involved in this incident has been identified with serial number: (b)(4), which means that it is a first generation of the piq design with 60 gram pods.The mattress was sold to (b)(6), which is a nursing home care.The pressure iq evolve mattress replacement system (atmosair helix) utilize a system of air filled bellows (pods) connected via a hosing configuration with sattm (self-adjusting technologytm) valve and inlet check valves.The tubing redistribute air between pods when a patient lies on the mattress surface thereby redistributing pressure to the patients as they lay on the surface.The helix system is surrounded by foam and encased in a mattress cover.A high quality visco-elastic and polyurethane foams improves patient comfort and immersion.A review of reportable events for evolve mattress revealed that although there were some complaints reported with an allegation of mattress bottoming out, after conducting a comprehensive evaluation of the product, it was concluded that the product is performing as intended regardless of minor defects (pods with holes, leak from the harness).The relation between mattress bottoming out and patient's developing skin breakdown could not have been confirmed.We have not found a complaint with an allegation of patient's death in relation to mattress failure, thus we concluded that this complaint seems to be an isolated incident.The mattress involved in the incident had an amount of indentation checked as per user manual by the customer.The measurement was 2.7 inch which is 0.2 greater than expected.User manual indicates that the mattress should have an indentation less than 2.5 inch as it is typical for this mattress after normal use.Evolve pressure mapping test reports, which tested mattresses in various conditions (e.G.Mattress valve reverse, mattress exhibiting maximum deformation - approximately 3 inches, a mattress subjected to 146000 articulation cycles, leak from tubing) shows that the mattresses were performing as intended even with the above mentioned defects.According to arjohuntleigh health hazard evaluation (hhe) dated on (b)(4) 2014 the hazard associated with the use of the mattress that exhibits concavity could range from "no adverse health consequences" to "limited (transient, minor impairment or complaints)" for the population at greatest risk (having other co morbidities, having skin integrity issues, at high risk for infection, dehydration, malnutrition, decreased mobility) because the increased immersion may make repositioning of the patient difficult or may cause discomfort to the patient.The probability that use of evolve mattress will cause any adverse events that would result in death, be life threatening, or results in permanent impairment for the overall population or the population at greatest risk is remote.The evolve mattress has the 3 inch high quality visco-elastic topper foam, which responds to patient size and may show an indentation at the body section of the mattress after use.Even if some mattress components failed there is still a foam layer that support a patient preventing immediate harm and allowing a caregiver to take actions according to user manual and/or (b)(6) guidelines.All devices in the field including all the 60 gram units function as designed and the risk requirements were met per our design failure modes and effects analysis.It is worth noting that user manual provided with each device informs the user about necessity to monitor skin conditions regularly and consider adjunct or alternative therapies for high acuity patients.No information regarding patient pre-existing condition was provided, also we have not received information about the patient condition when was taken off of the evolve mattress, however, taking into consideration test reports, hhe, complaint review it seems unlikely that mattress failure on its own could have been a contributory factor to the patient's outcome.It has been deemed unlikely that the evolve mattress failure (described as mattress experiencing indentation 2.7 inch) could have contributed to the patient's outcome in any way.We have not found a relation between the allegation of deterioration in patient's skin condition and later death.In summary, the mattress was being used with a patient and in that way was pointed to be involved in the complaint, the mattress failed to meet its specification since an indentation was found greater that indicated in user manual, however it could be shown based on the performed pressure mapping tests that even with some defects, the mattress could not be the cause of patient's demise.The 3 inch topper foam prevents immediate harm to the patient allowing the facility to take an appropriate actions according to user manual e.G.413657-ah rev.C and/or (b)(6) guidelines.The event was decided to be reportable to competent authorities due to patient's outcome and not product failure.
|
