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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS VISICU ECARECOORDINATOR

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PHILIPS VISICU ECARECOORDINATOR Back to Search Results
Model Number 45356456091
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/05/2016
Event Type  malfunction  
Manufacturer Narrative
Engineering investigated this issue through code review and patient data, and determined that it is associated with a software defect.When the software defect occurs, the patient's submitted measurements are not populated in the patient's data table.The clinician is unable to view the patient's measurements in the ecarecoordinator clinical user interface.The customer does receive adherence flags indicating the patient's measurements have not been received.Engineering continues to investigate and develop a correction to this issue.A supplemental report will be submitted.
 
Event Description
Customer reported that they were unable to view the patient's measurements (oximetry and blood pressure) in the clinical user interface of the device on the date of the incident.However, the customer could view the patient's measurements with a back end tool.The customer did not report any consequences to the patient.
 
Manufacturer Narrative
The correction for the defects was developed, tested and released.Philips is working with customers to implement the correction.
 
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Brand Name
ECARECOORDINATOR
Type of Device
ECARECOORDINATOR
Manufacturer (Section D)
PHILIPS VISICU
217 e. redwood st.
suite 1900
baltimore MD 21202
Manufacturer (Section G)
PHILIPS VISICU
217 e. redwood st.
suite 1900
baltimore MD 21202
Manufacturer Contact
cathleen hargreaves
217 e. redwood st.
suite 1900
baltimore, MD 21202
4108434590
MDR Report Key5535839
MDR Text Key41486108
Report Number1125873-2016-00022
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141706
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation Nurse
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/07/2016,05/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Model Number45356456091
Other Device ID NumberV.1.3
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Report to Manufacturer03/07/2016
Date Manufacturer Received04/07/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-1557-2016
Patient Sequence Number1
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