Model Number 90478 |
Device Problem
Device Alarm System (1012)
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Patient Problem
Ventricular Fibrillation (2130)
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Event Date 01/22/2016 |
Event Type
malfunction
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Manufacturer Narrative
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An onsite investigation of the involved devices performed by a spacelabs field service engineer confirmed that the involved devices worked to specifications.Spacelabs has launched an investigation into this event and will file a supplemental report when the investigation is complete.
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Event Description
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Spacelabs received a report that on (b)(6) 2016 at 3:19 a.M.No alarm was generated for a 12 beat run of vtach (ventricular tachycardia) from a patient monitored with telemetry transmitter model 91343, telemetry receiver module model 90478 and telemetry central monitor model 91387-38.There was no report of injury for this event.
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Manufacturer Narrative
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The patient's historical waveforms and trend information were reviewed by a spacelabs lead software engineer.The historical waveforms show a 15 beat run of ventricular tachycardia at 3:18:35am on (b)(6) 2016, and it was confirmed that all of the beats in the episode were accurately detected.The investigation findings show that some beats were recognized as learned dominant beats, therefore the episode did not meet the criteria to generate a run alarm.The device performed to specifications.This report is considered final and the issue is closed.
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Search Alerts/Recalls
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