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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VISICU, INC ECARECOORDINATOR

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VISICU, INC ECARECOORDINATOR Back to Search Results
Model Number 453564506091
Device Problem Programming Issue (3014)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
If a patient generates an adherence flag on the final day of the patient's ir, the patient's intervention expired field is not being set, and no check patient calendar task will be generated for the patient.
 
Manufacturer Narrative
Philips q and r has completed the investigation for the reported failure of protocols ending without notice (rns are unaware) with the ecare companion home telemonitoring system. This complaint has been confirmed and a fix was implemented via fco 1125873-10-06-16-017-c in software version 1. 4. 0. 5. Q&r will continue to monitor for trends.
 
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Brand NameECARECOORDINATOR
Type of DeviceECARECOORDINATOR
Manufacturer (Section D)
VISICU, INC
217 e redwood st ste 1900
baltimore MD 21202
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
justin minor
217 e redwood st ste 1900
baltimore, MD 21202
MDR Report Key6030456
MDR Text Key57866288
Report Number1125873-2016-00043
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 Service and Testing Personnel
Remedial Action Modification/Adjustment
Type of Report Initial,Followup
Report Date 10/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2016
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 Received09/19/2016
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 Reuse

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