MAUDE Adverse Event Report: VISICU, INC. ECARECOORDINATOR

Model Number 453564506091

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2015

Event Type  malfunction  

Event Description

Philips visicu received a report from a health system user that the out of bounds weight flag did not trigger as expected by the clinical team.

Manufacturer Narrative

Remote connectivity will be used to evaluate the software at the health system.Initial investigation determined the patient had weight intervention rules that watched for a change in weight (increase and decrease) over 3 days for 1, 3, 5 lbs.The patient took a weight measurement on (b)(6) of (b)(6) and on (b)(6) and both of these measurements were delivered to pts/message broker at the same time.It appears that when measurements are received from the message broker, they are typically received in chronological order.But, when the messages are received at the same time, occasionally, the messages may be received out of order.When this occurs, a measurement may not correctly be evaluated for these over time intervention rules, because the past data it should be compared against haven't yet been received.Complaint history files were reviewed and this issue has not been previously reported.Although there has not been an allegation of harm at this time, philips visicu is conservatively reporting this issue based on the information known at this time at management's discretion.All available information has been placed on file in quality assurance for appropriate tracking and trending.Instructions for use have the following warnings: philips ecare coordinator (ecc) is a supplemental monitoring service; the patient's primary care provider is responsible for patient monitoring and follow-ups.Flag indicators, alone, should not be used to make clinical decisions.If additional information becomes available, a follow up report will be submitted within 30 days of the manufacturer receiving new information.

Manufacturer Narrative

Upon further investigation, it was determined that this issue meets the requirements of a reportable correction.

Event Description

(b)(4).

• Brand Name: ECARECOORDINATOR
• Type of Device: ECARECOORDINATOR
• Manufacturer (Section D): VISICU, INC.; baltimore MD
• Manufacturer Contact: chris ferguson ; 217 e. redwood st., ste. 1900; baltimore, MD 21202 ; 4102465382
• MDR Report Key: 4894283
• MDR Text Key: 6542449
• Report Number: 1125873-2015-00012
• 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,health professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/06/2015

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: Health Professional
• Device Model Number: 453564506091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 1125873-2015-00012
• Patient Sequence Number: 1