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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CERNER CORPORATIONMONITOR, PHYSIOLOGICAL

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CERNER CORPORATION MONITOR, PHYSIOLOGICAL   Back to Search Results
Model Number DASH AND SOLAR MONITOR (AMONG OTHERS)
Event Date 12/11/2008
Event Type  No Answer Provided  
Event Description

Nurses are currently manually entering vital signs data into the electronic medical record (emr). Nurses have noticed that the mean pressure value that is calculated by the emr is sometimes different from the mean value displayed on the patient monitor. A few sample values were obtained: (systolic/diastolic mean) 129/65 81 emr mean 86; 146/78 95 emr 101; 134/54 81 emr 84; 150/98 116 emr 115. We were unable to verify if this occurs with a different patient monitoring vendor (such as in the er) because in that case the emr does not display the mean value. Nurses reporting this problem say that they have seen much larger variations but i do not have specific numbers to report yet. ====================== manufacturer response for patient monitor, (brand not provided)======================per clinical support with ge, the mean pressure is measured in the oscillometric method and is the most accurate pressure value since the systolic and diastolic are then calculated from the mean. Most emr's take the systolic and diastolic numbers and then calculate the mean using a formula intended for auscultatory readings. Therefore there will be variations.

 
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Type of DeviceMONITOR, PHYSIOLOGICAL
Manufacturer (Section F)
CERNER CORPORATION
2800 rockcreek parkway
kansas city MO 64117
Manufacturer (Section D)
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 tower avenue
milwaukee WI 53223
Device Event Key1349757
MDR Report Key1288623
Event Key1228954
Report Number1288623
Device Sequence Number2
Product CodeMHX
Report Source User Facility
Type of Report Initial
Report Date 12/17/2008
2 DeviceS WERE Involved in the Event:1 2 
1 Patient Was Involved in the Event
Date FDA Received12/18/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Invalid Data
Device MODEL NumberDASH AND SOLAR MONITOR (AMONG OTHERS)
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/18/2008
Device Age6 yr
Event Location Hospital
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Patient TREATMENT DATA
Date Received: 12/18/2008 Patient Sequence Number: 1
#TreatmentTreatment Date
NOT APPLICABLE
NOT APPLICABLE
NONE
NONE
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