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Model Number 172520 |
Device Problem
Non Reproducible Results (4029)
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Patient Problem
Electric Shock (2554)
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Event Date 09/06/2019 |
Event Type
Injury
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Manufacturer Narrative
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The device was built 2009 and from testing from (b)(6) 2019, the electrical safety test with no errors.The device has been in operation for 10 years.In the initial report by the customer, it is described that at the same time construction work by the electrician in the next control cabinet took place.The device was subsequently tested for electrical safety by our technician in denmark and no fault was found.The electrical test does not see anything that could be a hazard to patient as all values/limits are met.Based on the information made available to vyaire medical, the electrical shock may have been attributed by the work of the electrician.This incident may be due to the protective conductor briefly assumed the potential of the phase.Meaning all device-internal security systems are "abused" and the phase can reach the patient right up to the last grounding point.The thesis is corroborated by the statement that "all the lights, computers in the room shuts down together with the master screen equipment." additionally, the customer reported the device was placed put back into operation at the clinic's request.
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Event Description
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The healthcare facility reported during pulmonary function testing, the patient allegedly received an electrical shock.The patient is connected to the equipment through a plastic mouthpiece in which there is a filter attached to the electronics that is controlled by the master screen system.The nurse reported the incident occurred during the flow-volume curve (fvc) at the end of the exhalation.Just before the end-of-test (eot) criteria was reached, the patient fell/jumped backwards, and passed out for a few seconds.The healthcare facility confirmed at the time of the incident all of the light/power in the room disappeared.Additionally, the reported incident occurred at the same time construction work by the electrician in the next control cabinet took place.The patient has no recollection of a strange sound, and no recollection if the patient did or did not touch any part of the hardware.The patient has no recollection of getting zapped or what happened.The patient was transferred to the trauma center for observation.No further information about an injury or condition of the patient.
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Search Alerts/Recalls
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