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 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

It is noted that this adverse event report was split from mdr 1125873-2016-0002 as it was identified that there were two occurences of the same defect.The event that is addressed in this adverse event report occurred on (b)(6) 2016 and the measurements were blood pressure and spo2.Engineering investigated this issue through code review and patient data; and determined that it is associated with a software defect.When the software defect occurs, the patient's submitted measurements are not populated in the patient's data table.The clinician is unable to view the patient's measurements in the ecarecoordinator clinical user interface.The clinician will not receive any flags to indicate that the measurements were not process correctly, and intervention rules will not be properly applied.Engineering continues to investigate and develop a correction to this issue.A supplemental report will be submitted.

Event Description

Customer reported that they were unable to view the patient's measurements in the clinical user interface of the device for (b)(6) 2016.However, the customer could view the patients measurements with a back end tool.The customer did not report any consequences to the patient.

Manufacturer Narrative

This report is being submitted to document additional information.

Event Description

This report is being submitted to document additional information.Contains information regarding the corrective action.A correction to the software defect has been developed and will be implemented with customers.

• 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 MD 21202
• Manufacturer Contact: cathleen hargreaves ; 217 e. redwood st.; suite 1900; baltimore, MD 21202 ; 4108434590
• MDR Report Key: 5506288
• MDR Text Key: 40526688
• Report Number: 1125873-2016-00015
• 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: 02/17/2016,04/12/2016

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: Nurse
• Device Model Number: 45356456091
• Other Device ID Number: V.1.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Report to Manufacturer: 02/17/2016
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2016
• 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: Reuse
• Removal/Correction Number: 1125873-04-01-2016-009-C
• Patient Sequence Number: 1
• Patient Age: 82 YR