Model Number 91496 |
Device Problem
Device Alarm System (1012)
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Patient Problem
Ventricular Tachycardia (2132)
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Event Date 07/12/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The customer¿s biomed tested the module and could not reproduce the symptom.The biomed is sending the module to spacelabs for additional testing.Spacelabs has attempted to collect historical waveforms and trend data from the ics database, but due to the amount of time from the date of occurrence to when the customer reported the issue, the data had already been purged.Spacelabs has launched an investigation and will file a supplemental report once the investigation is complete.
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Event Description
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Spacelabs received a report that on (b)(6) 2016 at approximately 4:00 am, a run of ventricular tachycardia (vtach) did not alarm for vrun at bedside or central monitor.No one was injured as a result of this event.
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Manufacturer Narrative
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The customer biomed tested the involved devices and could not reproduce the symptom.A spacelabs field service engineer went on-site and confirmed that all tests passed.The customer opted to send the nine year old device to spacelabs depot repair for further evaluation.The patient's historical waveforms and trend information were no longer available because the data had been purged.Spacelabs service center received the device and the cpu board was replaced, however no correlation could be made between the replaced part and the reported event.The repaired unit passed all functional tests and was restored to service.This report is considered final and the issue is closed.
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Search Alerts/Recalls
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