Customer reported that during patient use, the autopulse platform s/n (b)(4) would only partially retract and the message of "realign patient" displayed.Summary of event: on (b)(6) 2015 at 9:19 am the ems were called to a place of business on a (b)(6) male, who had suffered cardiac arrest.The event was not witnessed.The patient was last seen one hour prior.A co-worker found the patient and started bystander cpr at 9:22 am.The local fire department were the first responders.The first responders performed manual cpr starting at 9:26 am, until the ems arrived and started to set up the autopulse for compressions at 9:50 am.There was a 30 second delay from manual cpr to the patient being placed on the autopulse platform to start compressions.The ems had no difficulty starting the autopulse.However, the lifeband would not retract as normal and did not tighten around the patient.It only retracted a few inches.An error message displayed to "realign patient and restart." the ems realigned the patient and restarted the autopulse.The same error occurred.The ems attempted to realign and restart two times.The ems was not able to get the autopulse to function as normal.They reverted to manual cpr, no compressions were ever done on the patient with the autopulse.The patient was being treated with manual cpr and achieved rosc (return of spontaneous circulation) for 1 minute at 9:51 am and again for 5 minutes at 9:53 am.The patient was transported to the hospital.It was reported that the patient expired at the hospital, time unknown.No patient information disclosed.No further information provided.
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The autopulse platform was returned to zoll for investigation on 12/11/15.Visual inspection of the returned platform was performed; front cover was cracked and load plate cover was noted to be defective.The autopulse platform is a reusable device and was manufactured on 02/17/2009.Therefore, this type of physical damages found during visual inspection is characteristic of normal wear and tear for the life of the device and not related to the reported complaint of the autopulse displaying "realign patient" message.A review of the archive was performed and multiple faults were noted on the date of the events (b)(6) 2015.User advisory (ua) 07 (discrepancy between load 1 and load 2 too large) and ua 2 (compression tracking error).It was not possible to perform functional testing on the device as the drive train motor brake gap was too tight.In summary the customer's reported complaint is confirmed.The root cause for the reported complaint is the load imbalance between left and right sides of the load plate.In this incident it is possible that the patient was not placed on device correctly or patient was possibly moving on the board during compression.Load cell characterization testing was also performed, and confirmed that both load cell modules are functioning within the specification.A brake gap inspection was performed and verified that the brake gap was out of the specification which is unrelated to the reported complaint.The break gap was adjusted back within the specification.The functional test was performed using the 95% patient test fixture (lrtf) for several hours, and did not duplicate any of the user advisory or fault.It should be noted that autopulse is adjunct to manual cpr.In case of stoppage of autopulse the user reverts to manual cpr.If an autopulse unexpectedly stops compressions, it is not likely to cause or contribute to a patient death or serious injury.
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