MAUDE Adverse Event Report: PHILIPS VISICU ECARECOORDINATOR; ECARECOORDINATOR V.1.2

Model Number 453564506091

Device Problems Failure to Fire (2610); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

Customer reported that a patient did not generate adherence flags even though the patient had tasks assigned for the day and the patient did not submit any measurements.Investigation reviewed the error logs associated with the time the flags should have been generated.Further investigation identified that the time based workflow rules (adherence flags) run in batch (500/hr).This was different than what was expected and the program generated the error as a result of too many queries, resulting in the flags not triggering.Engineering is developing a corrective action associated with this issue.

Event Description

User facility reported that the patient missed measurements and the expected missed measurement flags did not trigger as expected.The clinician did not indicate any harm or consequences to the patient as the result of this issue.

• Brand Name: ECARECOORDINATOR
• Type of Device: ECARECOORDINATOR V.1.2
• 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.; baltimore, MD 21202 ; 4108434590
• MDR Report Key: 5151232
• MDR Text Key: 28303618
• Report Number: 1125783-2015-00021
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Report Date: 10/14/2015

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: Nurse
• Device Model Number: 453564506091
• Other Device ID Number: V.1.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• 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
• Patient Sequence Number: 1