Catalog Number 60000000 |
Device Problems
Computer Software Problem (1112); Use of Device Problem (1670)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 09/06/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.H3 other text : the device was not returned.
|
|
Event Description
|
It was reported that the arctic sun device had no symbol but had not come back since and also stated that they had issues with electronic medical record (emr) and asked to have the customer call the tech support number because they were around the device and was texting this info.
|
|
Manufacturer Narrative
|
Per investigator evaluation, bd has determined that this mdr event is not reportable.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.H3 other text : the device was not returned.
|
|
Event Description
|
It was reported that the arctic sun device had no symbol but had not come back since and also stated that they had issues with electronic medical record (emr) and asked to have the customer call the tech support number because they were around the device and was texting this info.Per follow up information tech via phone on 06oct2023, it was reported that the control panel had to be recalibrated or reset.Once this was done, the issue was resolved.
|
|
Search Alerts/Recalls
|