MAUDE Adverse Event Report: GE MEDICAL SYSTEMS IFORMAITON TECHNLOGIES, INC. GE SOLAR 800I PATIENT MONITOR; CARDIO/RESPIRATORY MONITOR

Model Number SOLAR 800I

Device Problem Device Alarm System (1012)

Patient Problem No Information (3190)

Event Date 12/16/2014

Event Type  malfunction  

Event Description

Patient experiencing bradycardia and the monitor did not alarm when the heart rate dropped below the low limit of 100 bpm.The apnea wring also did not sound crisis alarm sounded when heart rate was in the 60s.

• Brand Name: GE SOLAR 800I PATIENT MONITOR
• Type of Device: CARDIO/RESPIRATORY MONITOR
• Manufacturer (Section D): GE MEDICAL SYSTEMS IFORMAITON TECHNLOGIES, INC.; 8200 west tower ave; milwaukee WI 53223
• MDR Report Key: 4390363
• MDR Text Key: 5305919
• Report Number: 4390363
• Device Sequence Number: 1
• Product Code: DRT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/17/2014

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: Other
• Device Model Number: SOLAR 800I
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2014
• Distributor Facility Aware Date: 12/16/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/02/2015
• Patient Sequence Number: 1