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

Device Problem Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2021

Event Type  malfunction  

Event Description

Omnicell machine shutdown and needed to be re-booted.The printer was printing labels offline.No harm to the patient.

• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): OMNICELL, INC.; 500 cranberry woods drive; cranberry township PA 16066
• MDR Report Key: 12413741
• MDR Text Key: 269541870
• Report Number: 12413741
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1