MAUDE Adverse Event Report: PHILIPS VISICU ECARECOORDINATOR; ECARECOORDINATOR V.1.2, PRODUCT CODE: DRG

Model Number 453564506091

Device Problem Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2015

Event Type  malfunction  

Manufacturer Narrative

Customer reported that flags for missed measurements did not trigger as they were supposed to for the patient.Investigation reviewed the data 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 note that this report was originally submitted on (b)(6) 2015 with an incorrect manufacturer fda registration establishment.A digit was transposed.The report was submitted under 1125783 versus the correct registration establishment number of 1125873.Fda contacted us in (b)(6) of 2020 stating they could not find the initial report.The initial report is being resubmitted at the request of fda.

Event Description

User facility reported that flags for missed measurements did not trigger as they were supposed to for this patient.The clinician did not indicate an harm or consequences to the patient as the result of this issue.

• Brand Name: ECARECOORDINATOR
• Type of Device: ECARECOORDINATOR V.1.2, PRODUCT CODE: DRG
• Manufacturer (Section D): PHILIPS VISICU; 217 e. redwood st.; suite 1900; baltimore, md
• Manufacturer (Section G): PHILIPS VISICU; 217 e. redwood st.; suite 1900; baltimore, md
• Manufacturer Contact: ingrid sawvelle ; philips visicu; 217 e. redwood st.; baltimore, md ; 2761960
• MDR Report Key: 5207295
• MDR Text Key: 199991371
• Report Number: 1125873-2015-00022
• 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 Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/15/2015

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: Health Professional
• Device Model Number: 453564506091
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2015
• Initial Date FDA Received: 11/06/2015
• 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