Model Number 16413 |
Device Problem
No Display/Image (1183)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 06/16/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Evaluation is in progress, but not yet concluded.Per field service representative (fsr), the arterial monitor functions to specification.The fsr could not duplicate the complaint.A replacement monitor was installed.The unit is operating within manufacturer's specifications.Unit was returned to manufacturer for additional evaluation.
|
|
Event Description
|
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the display for arterial pressure was not showing any information.They used cardioplegia monitor channel b in place of arterial pressure for this case.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
|
|
Manufacturer Narrative
|
During laboratory analysis, the product surveillance technician (pst) connected the monitor to power supply and connected a pressure simulator to the input of the monitor and the monitor operated for eight hours with no failure of the monitor.The pst soaked the monitor at 10°c for three hours and when removed it displayed pressure.The pst operated the monitor for 72 hours with no failure on the monitor to display pressure.The pst agitated the internal connections and circuit boards with no failure of the monitor to display pressure.
|
|
Manufacturer Narrative
|
The reported complaint was not confirmed.The field service representative (fsr) replaced the power board in the safety monitor.This board supplies power to the arterial monitor and may have an intermittent problem.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
|
|
Search Alerts/Recalls
|