MAUDE Adverse Event Report: GE HEALTHCARE CARESCAPE B650 SMART BATTERY; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR

Model Number FLEX-3S3P

Device Problems Device Displays Incorrect Message (2591); Battery Problem (2885)

Patient Problem No Information (3190)

Event Date 05/22/2014

Event Type  malfunction  

Event Description

Battery failure message appeared on the b650 patient monitor.The battery was moved to another device and the battery failure followed with the battery to that monitor.To troubleshoot further, the unit was unplugged and ran on battery for 60 seconds and plugged back in.The battery failure went away upon re-powering the unit.

• Brand Name: CARESCAPE B650 SMART BATTERY
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR
• Manufacturer (Section D): GE HEALTHCARE; 9900 w. innovation drive, rp21; wauwatosa WI 53226
• MDR Report Key: 3918227
• MDR Text Key: 4513666
• Report Number: 3918227
• Device Sequence Number: 1
• Product Code: MHX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 06/03/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: FLEX-3S3P
• Device Catalogue Number: U80206
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 9 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.