Model Number 90496 |
Device Problem
Device Alarm System (1012)
|
Patient Problem
Ventricular Tachycardia (2132)
|
Event Date 06/24/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
The involved devices were tested and all the equipment performed to specifications.The retrospective patient data was sent to spacelabs for evaluation.Spacelabs will file a supplemental report once the investigation is complete.
|
|
Event Description
|
Spacelabs received a report that on (b)(6) 2016 at 11:26 pm, a run of ventricular tachycardia (vtach) did not alarm at bedside or central, but was captured in clinical access (the retrospective database application).No one was injured as a result of this event.
|
|
Manufacturer Narrative
|
Onsite testing of the involved devices by a spacelabs field service engineer confirmed the equipment performed to specifications.The testing was witnessed by a facility staff member.The patient retrospective database was provided by the customer for review by a spacelabs software lead engineer.The reported event (a run of ventricular tachycardia) which the customer observed on (b)(6) 2016 at 11:26 pm did meet the criteria for a run alarm and in the database as well as a print job shows that the monitor generated a run alarm as appropriate.Based upon the investigation, we have concluded that the device did not malfunction.This investigation is considered complete and the issue closed.
|
|
Search Alerts/Recalls
|