MAUDE Adverse Event Report: VISICU, INC ECARECOORDINATOR

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.

• Brand Name: ECARECOORDINATOR
• Type of Device: ECARECOORDINATOR
• 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 Key: 6030456
• MDR Text Key: 57866288
• Report Number: 1125873-2016-00043
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141706
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 453564506091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2017
• 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: Reuse
• Patient Sequence Number: 1