MAUDE Adverse Event Report: PHILIPS VISICU ECARECOORDINATOR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Weight Changes (2607)

Event Date 08/29/2015

Event Type  No Answer Provided  

Event Description

The customer reported that in ecare coordinator, the enrolled patient had flags for both decrease and increase in weight.For example, today's weight shows a decrease compared to the past 8 days.Customer questioned the inconsistency of data.There was no reported consequences to the patient.

Manufacturer Narrative

Engineering has developed a corrective action associated with this issue.The corrective action is being deployed to the affected customers.

Event Description

This report is being submitted as a follow up report.

• Brand Name: ECARECOORDINATOR
• Type of Device: ECARECOORDINATOR
• Manufacturer (Section D): PHILIPS VISICU; 217 e. redwood st.; suite 1900; baltimore MD 21202
• MDR Report Key: 5110434
• MDR Text Key: 27184962
• Report Number: 1125873-2015-00017
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Remedial Action: Recall
• Type of Report: Followup
• Report Date: 11/06/2015

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2015
• Type of Device Usage: N
• Removal/Correction Number: 1125873-08-24-15-019-C
• Patient Sequence Number: 1