MAUDE Adverse Event Report: GE HEALTHCARE SEER EVENT MONITOR; CARDIAC MONITOR

Catalog Number 2043290-105

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Information (3190)

Event Date 03/02/2015

Event Type  malfunction  

Event Description

The seer event monitors have a consistent problem with either staying in calibration mode or not transmitting.We are having repeated problems with these devices.There are no common variables regarding when or if the monitors will become stuck in calibration mode.Once in calibration mode and stuck, the monitor beeps/alarms continuously that it is in calibration mode.Staff are unable to "un-stick" the monitor: biomed is contacted and removes/replaces the monitor.The monitors are then sent back to the manufacturer to have their password reset.We are seeing this problem in multiple monitors consistently for the last three months.Some devices are less than one year old and still under warranty.Others are older.To date, 15 monitors have been returned to the manufacturer since october of last year.
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manufacturer response for cardiac monitor, seer event monitor (per site reporter).
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ge healthcare replaces the old monitor with a new at $777 per one and i have returned 15 monitors since october of 2014.

• Brand Name: SEER EVENT MONITOR
• Type of Device: CARDIAC MONITOR
• Manufacturer (Section D): GE HEALTHCARE; 9900 w. innovation dr., rp 213; wauwatosa WI 53226
• MDR Report Key: 4826769
• MDR Text Key: 5914619
• Report Number: 4826769
• Device Sequence Number: 7
• Product Code: DRT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/26/2015
• 14 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14

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 Catalogue Number: 2043290-105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/26/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2015
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES