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 04/18/2016

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.It was determined that this patient was suspended for a short period ((b)(6) 2016) during their current episode of care.The patient only missed on survey on (b)(6) 2016.When the patient was reactivated, the clinician did not adjust the patient's schedule.On (b)(6) 2016, the customer went into the patient calendar and either re-saved or made a modification to the calendar and then saved.The calendar action caused the patient tasks to be updated and delivered properly.This issue occurs when the patient is in the suspended status, there are no new tasks (measurement and/or survey) generated 14 days out from the dates that patient is suspended for.This issue results in the following: a patient not getting a task reminder; an adherence check/flag will not be completed as there is no task to trigger; a new task will not be generated 14 days out.Intervention rules will trigger (if the patient is within the same episode).The investigation continues and a supplemental report will be filed.

Event Description

The customer reported that several patients had not received daily surveys within the past few days.The customer provided two patient id's, the issue reported on this medical device report and the other example is reported on 1125873-2016-00037.The customer did not report any impact or consequences to the patient.

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: ECARECOORDINATOR
• 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 21202
• Manufacturer Contact: cathleen hargreaves ; 217 e. redwood st.; suite 1900; baltimore, MD 21202 ; 4108434590
• MDR Report Key: 5660893
• MDR Text Key: 45366510
• Report Number: 1125873-2016-00036
• 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

• 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
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/12/2016
• 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: 68 YR