Model Number HT70 |
Device Problem
Device Inoperable (1663)
|
Patient Problem
No Code Available (3191)
|
Event Date 05/10/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device evaluation: the engineer evaluated the ventilator and replaced the pump.The ventilator passed all testing per the service manual specifications and was returned to the customer for clinical use.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that during use on a patient the ht70 ventilator has generated an " motor error alarm" and stopped ventilation.Patient was removed from the ventilator and placed on an alternate ventilator with no harm reported.
|
|
Manufacturer Narrative
|
Device evaluation summary: one pump/manifold assembly was received by failure investigations for analysis.The issue of a motor error alarm was not confirmed; however, an alternate failure was observed.The pump had debris in the pistons.This was caused by worn linear piston bearings.The event will be included in trending and monitoring.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|