MAUDE Adverse Event Report: OMNICELL, INC. OMNICELL; WORKSTATION

Model Number ANT-FRM-001

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 03/21/2016

Event Type  malfunction  

Event Description

Omnicell in anesthesia area was set to reboot.Began to emit a considerable amount of smoke.Fire not seen but suspected.Omnicell removed from operating room, no patient in room.Technician removed ebox.

• Brand Name: OMNICELL
• Type of Device: WORKSTATION
• Manufacturer (Section D): OMNICELL, INC.; mountain view CA 94043
• MDR Report Key: 5535536
• MDR Text Key: 41528172
• Report Number: MW5061336
• Device Sequence Number: 1
• Product Code: NEP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/25/2016

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
• Device Model Number: ANT-FRM-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1