Model Number 801188 |
Device Problem
Failure to Calibrate (2440)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
|
Event Date 10/01/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
During laboratory analysis, the product surveillance technician (pst) observed the electronic patient gas system (epgs) to fail calibration.Upon inspection, the oxygen (o2) sensor cartridge was found to be leaking.A lab use only o2 sensor cartridge was installed on the user facility epgs and the unit passed calibration with no errors.
|
|
Event Description
|
Additional information was received that an alternate device was employed.There was no delay, no blood loss, nor adverse consequences to the patient.
|
|
Manufacturer Narrative
|
The field service representative (fsr) removed the epgs and oxygen (o2) sensor and found no abnormalities.He reinstalled the system and calibrated 10 times without failure.The next day, the issue reoccurred and he verified the reported complaint.The epgs failed calibration on his first attempt.He replaced the epgs.The unit operated to the manufacturer's specifications.The suspect unit was returned to the manufacturer for further evaluation.This complaint is related to (b)(4) / medwatch #1828100-2019-00557.
|
|
Event Description
|
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the electronic patient gas system (epgs) failed calibration.No other details regarding the nature of this event were provided.
|
|
Event Description
|
Additional information received that a trouble shooting was performed and eventually bypass was run on 100 percent (%) fraction of inspired oxygen (fio2).
|
|
Manufacturer Narrative
|
The service repair technician (srt) replaced the oxygen (o2) sensor as part of the reconditioning process.The unit operated to the manufacturer's specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
|
|
Manufacturer Narrative
|
Per the perfusionist, the hospital shut down the medical air system due to troubleshooting and maintenance right as the case started.As a result of that work, the medical air was being shut off and turned back on, affecting the pump's calibration status.
|
|
Event Description
|
Additional information was received that the surgical procedure was completed successfully.
|
|
Search Alerts/Recalls
|