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 03/22/2016

Event Type  malfunction  

Manufacturer Narrative

Engineering investigated this issue through code review, transmission data and patient data; and determined that the issue with blood pressure 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 ecare coordinator clinical user interface.The customer does receive adherence flags indicating the patient's measurements have not been received.The spo2 and the weight transmitted with minimal delay.The survey experienced a 30 minute delay in transmission.A correction to the software defect has been developed, reviewed and approved.The correction is released and philips visicu is working with customers to implement.

Event Description

Customer reported that they were unable to view the patient's measurements (blood pressure, weight, oximetry and survey) in the clinical user interface of the device on the date of the incident.However, the customer could view the patient's measurements with a back end tool.The customer did not report any consequences to the patient.

• 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: 5591515
• MDR Text Key: 43176312
• Report Number: 1125873-2016-00033
• 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,other,use
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• 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 Manufacturer Received: 03/22/2016
• 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: Reuse
• Removal/Correction Number: 1125873-04-01-2016-009-C
• Patient Sequence Number: 1
• Patient Age: 70 YR