|
On (b)(6) 2016, arjohuntleigh has been informed about an incident at (b)(6) hospital on an enterprise bed and atmosair 9000 mattress overlay.A pediatric patient expired after the unexpected cardiac arrest and ineffective cpr performance.After activating cpr function on the enterprise bed, the hospital employee according to their internal procedures, placed the head board underneath the mattress to provide support during the resuscitation.Initially the headboard was claimed not to be removed easily and during investigation it was established that the reason for that was the fact it was locked as it should not have been.Moreover the hospital personnel stated that surface was too soft and they were unable to provide adequate compression, even with the back board in place.The headboard was not found to be faulty.The serial number of the mattress and bed involved is unknown as the actual devices cannot be identified.The atmosair mattress as well as the enterprise bed were "overflow" units at this facility and were not assigned per serial number to a room or to a patient.They are cycled through inventory and active use based on the need of different areas of the facility.It was reported that neither unit was quarantined and both were cycled back into either inventory or active use.With the information gathered to date, there is no evidence to confirm any evidence of the device malfunction that would cause the adverse event occurrence or contribute to the patient outcome.The instruction for use ((b)(4)) includes information about the cpr procedure for those mattresses models equipped with the pump unit.Since the serial and model number of mattress involved was not provided it is unknown if this is relevant.Nevertheless it is recommended to level the bed, disconnect hoses from the pump, lower or remove side rails and being the cpr.Every facility has its own cpr protocol which shall be followed in case of emergency situation.The generally available literature widely describes that the cpr is most easily and effectively performed by laying the patient supine on a relatively hard surface, which allows effective compression of the sternum; it seems quite incomprehensible that the hospital staff placed the headboard underneath the mattress cells rather than between the patient and the mattress to ensure efficient compression on a hard surface.Based on the limited information provided we cannot determine any malfunction of the mattress nor claim that was not fully functional as designed.The human factor that had an impact on the incident outcome cannot be excluded.This complaint was determined to be reportable to competent authorities based on the patient outcome.In summary, the inspection of the device involved in the event was not possible due to the fact that it was an overflow unit at user facility, nevertheless there are no evidences to confirm any device malfunction during the event occurence.The review of post market surveillance data confirms no similar complaint in the past was recorded and we consider this to be unfortunate incident.
|
