MAUDE Adverse Event Report: PHILIPS VISICU ECARECOORDINATOR

Model Number 45356456091

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2016

Event Type  malfunction  

Manufacturer Narrative

The customer did not indicate any impact to the patient.This particular patient had taken their measurements, however, the patient triage screen was not indicating completion.Engineering investigated this issue remotely through code review and patient data; and determined that it is associated with a software defect.The issue occurs with the following steps: the clinician only saves the active patient's calendar 1 time; and the patient does not submit a measurement; the device attempts to generate an adherence flag.The software defect occurs.Two issues happen as a result of the software error: no adherence flag is generated for that day; and no task is generated 14 days later.Because there was no task, the patient triage screen did not update appropriately.A correction to the defect has been completed and is being implemented with customers.

Event Description

Customer reported that this patient had take their measurements.However, later in the day, the triage screen still showed that the patient had not taken their measurements.The customer re-created the patient's calender and this fixed the issue.There was no impact to the patient due to this issue.

Event Description

Supplemental report being submitted to correct the correction/removal reporting number.

• Brand Name: ECARECOORDINATOR
• Type of Device: ECARECOORDINATOR
• Manufacturer (Section D): PHILIPS VISICU; 217 e redwood st; suite 1900; baltimore MD 21202
• Manufacturer (Section G): PHILIPS VISICU; 217 e. redwood st.; baltimore MD 21202
• Manufacturer Contact: cathleen hargreaves ; 217 e. redwood st.; suite 1900; baltimore, MD 21202 ; 4108434590
• MDR Report Key: 5607638
• MDR Text Key: 43621107
• Report Number: 1125873-2016-00034
• 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,health
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/10/2016

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: No Information
• Device Model Number: 45356456091
• Other Device ID Number: V.1.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2016
• Initial Date FDA Received: 04/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 1125873-03-03-16-006-C
• Patient Sequence Number: 1