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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VISICU, INC - DUP ECARECOORDINATOR

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VISICU, INC - DUP ECARECOORDINATOR Back to Search Results
Model Number 453564506091
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Customer stated her pt are receiving multiple surveys and she is unable to clear the flags. Per customer: all patients that answer their survey has the exact same this show up moments later except only the first one has their name attached to it. It repeats unless then just do not answer it. When i try to acknowledge the flag for the survey it will not open the note to let me type anything. I went back in and charted more this is the message that came up when i had checked the alerts; including the survey score alert, then clicked the acknowledge button.
 
Manufacturer Narrative
Philips q&r has completed the investigation for the reported failure of multiple patient surveys received and unable to clear flags with the ecare companion home telemonitoring system. This complaint has been confirmed. The message broker logic relies on a year comparison instead of a date comparison to determine if a survey has already been scheduled. When the year changed from 2016 to 2017, the logic continuously failed until all surveys still pending with the year 2016 were resolved. An enhancement will be implemented in version 1. 5. 4. 2 sb to prevent the logic from failing in this manner in future year changes. Quality will continue to monitor for trends.
 
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Brand NameECARECOORDINATOR
Type of DeviceECARECOORDINATOR
Manufacturer (Section D)
VISICU, INC - DUP
217 e redwood st ste 1900
baltimore MD 21202
Manufacturer (Section G)
VISICU, INC.
217 e redwood st ste 1900
baltimore MD 21202
Manufacturer Contact
justin minor
217 e redwood st ste 1900
baltimore, MD 21202
MDR Report Key6263525
MDR Text Key65596387
Report Number1125873-2017-00001
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 company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Remedial Action Notification
Type of Report Initial,Followup,Followup
Report Date 01/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number453564506091
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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