MAUDE Adverse Event Report: PHILIPS VISICU ECARECOORDINATOR; ECARE COORDINATOR

Model Number 45356456091

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2016

Event Type  malfunction  

Manufacturer Narrative

The customer did not report any impact to the patient.Technical operations reviewed the code, error logs and patient data.Measurement icon is not updating because the patient does not have any patient tasks to associate the observation to.However this does not appear to be a defect and this is a customer workflow issue.When the patient was re-activated on (b)(6) 2016, following removal on (b)(6) 2016, they did not use the 'adjust schedule' button prior to re-activation.When the patient is in a removed or suspended state the system does not generate the next patient task in the series.That means after being suspended for a day if the calendar is not fixed by re-adjust or re-application of the protocol there will be a hole in the patients calendar.The investigation continues and a supplemental report will be filed.

Event Description

The customer reported that the patient took all required measurements between 8:06 and 8:20am on (b)(6) 2016 but at 3pm they are still showing they have not come in on the triage screen.They have been visible all morning.Customer checked his calendar and all tasks prior to today are missing as well.

Manufacturer Narrative

Investigation confirmed the design issue.A software correction has been developed and will be deployed on or about september 9, 2016.A field action has been initiated and customers have been informed of the issue, and the pending solution.

Event Description

This supplement report is filed to provide additional investigation information, as well as correction number.

• Brand Name: ECARECOORDINATOR
• Type of Device: ECARE COORDINATOR
• 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.; suite 1900; baltimore, MD 21202 ; 4108434590
• MDR Report Key: 5695559
• MDR Text Key: 46465713
• Report Number: 1125873-2016-00038
• 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,Followup
• Report Date: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 45356456091
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 1125873-07-12-16-014-C
• Patient Sequence Number: 1
• Patient Age: 90 YR