Model Number MAC 15.0.4 VERSION |
Device Problems
Computer Software Problem (1112); Data Problem (3196)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/11/2013 |
Event Type
malfunction
|
Event Description
|
A customer site reported that medical history condition data on the medical history screen of the pre-anesthesia evaluation (pae) application did not reflect the correct conditions.There were no adverse events or patient injuries resultant from the reported alleged malfunction.
|
|
Manufacturer Narrative
|
An investigation was performed using a simulated testing environment to determine the root cause of the reported event.The results of the investigation concluded that incorrect information was displayed on the pae screens of the reporting facility.Although the information was incorrectly displayed on the pae screen, the database storage and associated reports reflected the correct patient medical condition data.The actual defect did not occur every time and was sporadic in nature.Further analysis determined that the malfunction was likely caused by a defect in the device software.There have been no adverse events or patient injuries resultant from the reported alleged malfunction.
|
|
Search Alerts/Recalls
|