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Adverse Event Report

AGILENT TECHNOLOGIES, INC. VIRIDIA SURVEILLANCE CENTER CENTRAL STATION MONITOR   back to search results
Model Number M3153A
Event Type  Malfunction  
Event Description

The customer reported that the monitor did not alarm when the pt was disconnected from the ecg and a flatline ecg was displayed.

 
Manufacturer Narrative

Agilent technologies is still investigating this complaint and will send a follow-up report to the fda when the investigation is complete.

 
Manufacturer Narrative

It was reported that a fixed heart rate value appeared at a bedside monitor, even though the pt was disconnected from the ecg and a flat ecg line was displayed. The surveillance center was configured to flexibe mode. This bedside monitor was not currently assigned to a sector on the surveillance center because the user was attempting to use a 12 bed surveillance center in a 13 bed icu by reassigning sectors while pts were connected to the bedsides. After reassigning the monitor to a sector on the surveillance center, the real heart rate value was correctly shown at the surveillance center and at the bedside monitor. Upon de-assigning the monitor, the heart rate froze again. If the heart rate is frozen at the monitor, the monitor doesn't recognize any change in ecg and therefore, does not alarm. To address the customer's unusual use of the flexible monitoring capability, the customer was upgraded to a 16 bed surveillance center to support its 13 live bedside monitoring requirement. To investigate the incident, the engineering team configured a 12 bed surveillance center for 12 beds, and when they de-turned the bedside monitor from the central, the bedside was still expecting the central to provide arrhythmia detection and therefore continued to display the last updated vaule from the central (be it heart rate or inop). This condition remained until the central was either re-booted or the bedside is re-tuned to the central station. While the bedside is in this state, however, its internal cardio-tach and basic arrhythmia detection is shut off, disabling the bedside hr and v-fib/asystole alarm. This condition does not always occur when a monitored bed de-tunes from the central, as there appears to be a timing window that triggers this condition. The use model employed by this hosp has been determined to be unusual: the normal model is to only de-tune beds that have no pt on them. User and training documentation on the use of flexible monitoring capability indicates that de-tuning a bedside from the central station should be accomplished when the bedside is not in use. The customer's use modle of tuning and de-tuning an active bedside monitor with a pt connected was determined to be rare. The investigation determined that the static heart rate displayed on the bedside monitor was due to the customer's misapplication/misuse of the device.

 
Manufacturer Narrative

The customer has a 13 bed unit. Each bed has a bedside monitor. The customer has a central station with 12 pt sectors. The customer's use model was to clear an active bedside pt from the central station (while attempting to continue monitoring the pt from the bedside) to allow them to moniotr a different pt at the central station. As a result of this switching, which was outside the normal use model of the device, the bedside monitor displayed a static heart rate, which persisted after the ecg was disconnected from the pt.

 
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Brand NameVIRIDIA SURVEILLANCE CENTER
Type of DeviceCENTRAL STATION MONITOR
Baseline Brand NameAGILENT SURVEILLANCE CENTER
Baseline Generic NameCENTRAL STATION MONITOR
Baseline Catalogue NumberM3153A
Baseline Model NumberM3153A
Baseline Device FamilyARRHYTHMIA
Baseline Device 510(K) NumberK001057
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed03/01/1997
Manufacturer (Section F)
AGILENT TECHNOLOGIES, INC.
3000 minuteman rd.
andover MA 01810 1099
Manufacturer (Section D)
AGILENT TECHNOLOGIES, INC.
3000 minuteman rd.
andover MA 01810 1099
Manufacturer Contact
jean schubach
3000 minuteman road
andover , MA 01810-1099
(978) 659 -3956
Device Event Key299766
MDR Report Key309847
Event Key291214
Report Number1218950-2000-00251
Device Sequence Number1
Product CodeDRT
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility,Company Representative
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup,Followup
Report Date 11/16/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/19/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberM3153A
Device Catalogue NumberM3153A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/16/2000
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/1999
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on January 06, 2009

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