MAUDE Adverse Event Report: CLINICAL COMPUTER SYSTEMS, INC. OBIX; SYSTEM, MONITORING, PERINATAL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2015

Event Type  malfunction  

Event Description

We just discovered that a patient has been listed in obix in operating room 2 since her delivery (weeks ago).Unfortunately, numerous other tracings have also been traced under her name as her name did not drop out of the operating room when she was transferred out to another location.We have now manually discharged her from the obix system but this is a major issue that needs to be addressed.When discussing this, other rns at the desk mentioned that this happens frequently and that they have to move the patient back and forth in epic a few times in order for them to show in obix in the proper room.Note: some issue with the obix software does not always properly transfer the patient and data from other patients can flow into the record.

• Brand Name: OBIX
• Type of Device: SYSTEM, MONITORING, PERINATAL
• Manufacturer (Section D): CLINICAL COMPUTER SYSTEMS, INC.; 715 tollgate rd.; elgin IL 60123
• Manufacturer Contact: 715 tollgate road; elgin, IL 60123 ; 622-0847
• MDR Report Key: 5018003
• MDR Text Key: 23565299
• Report Number: 5018003
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Other Device ID Number: SOFTWARE REV.: 7.1.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: THE OBIX SYSTEM INTERFACES TO THE PATIENT'S ELECTR