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

Model Number 453564506091 V.1.2

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2015

Event Type  malfunction  

Manufacturer Narrative

Customer reported that flags for a patient's missed measurements did not trigger as they were supposed to.Investigation reviewed the data logs associated with the adherence flags that 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 has developed a corrective action associated with this issue.The corrective action is being deployed to the affected customers.

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 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.; 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.; suite 1900; baltimore, MD 21202 ; 4108434690
• MDR Report Key: 5211679
• MDR Text Key: 30836040
• Report Number: 1125873-2015-00024
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 453564506091 V.1.2
• Other Device ID Number: V.1.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2015
• 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: N
• Removal/Correction Number: 1125873-2015-019-C
• Patient Sequence Number: 1