Catalog Number 60000000 |
Device Problem
Failure to Calibrate (2440)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/09/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
|
|
Event Description
|
It was reported that biomed tried to do the calibration and keeps failing for an error 5 (inlet pressure out of range), the arctic sun device was due for the 2000 hour preventive maintenance and also to get the inlet pressure (ip) was checked out since it was reading -1.0 while stopped.
|
|
Event Description
|
It was reported that biomed tried to do the calibration and keeps failing for an error 5 (inlet pressure out of range), the arctic sun device was due for the 2000 hour preventive maintenance and also to get the inlet pressure (ip) was checked out since it was reading -1.0 while stopped.
|
|
Manufacturer Narrative
|
The reported issue was unconfirmed.The root cause of the reported issue could not be determined as the reported issue could not be reproduced.The reported event is unconfirmed, dhr review are not required.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
|
|
Search Alerts/Recalls
|