• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CERNER CORPORATION CAREAWARE IBUS SOFTWARE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CERNER CORPORATION CAREAWARE IBUS SOFTWARE Back to Search Results
Model Number CAREAWARE 6.5.0 CAREAWARE IBUS.2021W16 THROUGH CAREAWARE IBUS.2021W30
Device Problem Computer Software Problem (1112)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2021
Event Type  malfunction  
Manufacturer Narrative
Cerner distributed a flash notification on august 26, 2021 to all potentially impacted client sites. The software notification includes a description of the issue and a software modification has been developed to address the issue for all sites that could be potentially impacted. Cerner corporation considers this issue to be resolved and no further narrative is required for follow-up.
 
Event Description
This report documents information related to an issue identified with functionality included in cerner's careaware ibus®. This issue involves cerner's careaware ibus® and affects users that assign role based alerting in careaware® event management, which is used as a secondary mechanism to route event or alarm information to mobile phones or other computing or communications endpoints. If a personnel record is saved in cerner millennium, that personnel record can fail to set an organization identifier in careaware event management due to a defect in careaware ibus. If alerting is built based on roles, the clinician may not be notified appropriately of a secondary alert through careaware event management, which could lead to a delay in patient care. Cerner has not received communication on any adverse patient events as a result of this issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCAREAWARE IBUS
Type of DeviceSOFTWARE
Manufacturer (Section D)
CERNER CORPORATION
8779 hillcrest road
kansas city MO 64138
Manufacturer (Section G)
CERNER CORPORATION
8779 hillcrest road
kansas city MO 64138
Manufacturer Contact
shelley looby
8779 hillcrest road
kansas city, MO 64138
8162011368
MDR Report Key12378114
MDR Text Key268490594
Report Number1931259-2021-00016
Device Sequence Number1
Product Code DRG
UDI-Device Identifier00853023006012
UDI-Public(01)00853023006012(10)CAREAWAREIBUS6.0.5
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Administrator/Supervisor
Remedial Action Modification/Adjustment
Type of Report Initial
Report Date 08/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCAREAWARE 6.5.0 CAREAWARE IBUS.2021W16 THROUGH CAREAWARE IBUS.2021W30
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-