Model Number 550AHCT |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/02/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that there was an inconsistency in the temperature readings from the blood parameter monitor (bpm).There were no reported adverse consequences to the patient.No other details regarding the nature of this event were provided.
|
|
Manufacturer Narrative
|
Per the manufacturer's subsidiary, the arterial bpm probe was replaced.The unit was tested and preventative maintenance was done, the unit passed all testing.
|
|
Manufacturer Narrative
|
Updated.
|
|
Event Description
|
Additional information was received that the issue occurred during set-up of the device for a cardiopulmonary bypass (cpb) procedure.The surgical procedure was completed successfully.There was no blood loss nor adverse consequences to the patient.
|
|
Manufacturer Narrative
|
Updated blocks: h3 and h6.The reported complaint was not verifiable since the product was not returned for evaluation or testing.Multiple diligence attempts for part return were unsuccessful.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
|