It was reported that while a competitor was using the analyzer during a device changeout case the programmer "crashed" to a black screen without warning and was unable to provide pacing during that time.The programmer and analyzer were advised to be returned to service.No patient complications have been reported as a result of this event.It was further reported that the product was returned to service and via follow-up that the analyzer was being used to maintain cardiac support during preparation of the replacement (implantable heart) device.The analyzer then "crashed" without warning and the patient, who was pacemaker dependent went into asystole.The physician was able to plug the leads back into the old device to support the patient until the new device was able to take over.A second analyzer was available was used to finish the procedure.No further patient complications were reported.
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