Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OMNICELL, INC.; SYSTEM/DEVICE, PHARMACY COMPOUNDING
  • 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
 

OMNICELL, INC.; SYSTEM/DEVICE, PHARMACY COMPOUNDING Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 07/14/2021
Event Type  malfunction  
Event Description
When pulling the patient's morning (am) meds from the omnicell, the omnicell prohibited pulling the meds from the system and required the return back into the system to obtain the medications.When the meds were pulled, the nurse had to override the system to retrieve the meds.Cerner triggered her to waste the medications because it appeared that they had already been pulled.
 
Event Description
When pulling the patient's morning (am) meds from the omnicell, the omnicell prohibited pulling the meds from the system and required the return back into the system to obtain the medications.When the meds were pulled, the nurse had to override the system to retrieve the meds.Cerner triggered her to waste the medications because it appeared that they had already been pulled.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
SYSTEM/DEVICE, PHARMACY COMPOUNDING
Manufacturer (Section D)
OMNICELL, INC.
51 pennwood place
warrendale PA 15086
MDR Report Key12681040
MDR Text Key277938314
Report Number12681040
Device Sequence Number1
Product Code NEP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 10/11/2021,10/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/11/2021
Event Location Hospital
Date Report to Manufacturer10/22/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/22/2021
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/20/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age8030 DA
Patient SexMale
-
-