MAUDE Adverse Event Report: PHILIIPS VISICU ECARECOORDINATOR

Model Number 45356456091

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

The customer did not indicate any impact to the patient.Patient calendar was missing tasks.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.A correction to the defect has been completed and is being implemented with customers.

Event Description

Customer reported that a number of patients have adherence flags that are for future dates.Those particular patients have calenders(patient measurement schedules) that look weird.With tasks missing's or completely blank days).Customer compared to patients without future flags and those patients calendars appear as expected.The customer did not indicate any patient impact.

• Brand Name: ECARECOORDINATOR
• Type of Device: ECARECOORDINATOR
• Manufacturer (Section D): PHILIIPS 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: 5519629
• MDR Text Key: 40957460
• Report Number: 1125873-2016-00005
• 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
• Report Date: 03/23/2016

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: 02/29/2016
• Initial Date FDA Received: 03/23/2016
• 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: 1125873-03-03-2016-C
• Patient Sequence Number: 1