MAUDE Adverse Event Report: PHILIPS VISICU ECARECOORDINATOR

Model Number 45356456091

Device Problem Incorrect Measurement (1383)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2015

Event Type  malfunction  

Manufacturer Narrative

Initial investigation into the event identified that the patient submitted a 1.0 lb decrease from the previous day's measurement but the system triggered a weight increase flag.In reviewing the patient records, the measurements sent by the patient over the past 8 days show that the patient had a (b)(6).The investigation determined the reason for the weight increase flag is that the system intervention rule evaluates the difference of the largest and the smallest value over the defined number of days.If the change in measurement meets the requirements, the intervention rule flags.The decrease measurement works similarly, it evaluates difference between the smallest value and largest value over a defined number of days.If the change in measurement meets the requirements after the set number of days the intervention rule flags.The two rules are applied separately, and as the patient experienced both a larger weight gain and smaller weight loss, with only the weight gain meeting the requirements, the weight gain was flagged.

Event Description

The customer stated that the enrolled patient's weight gain flag that they received was incorrect.There were 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.Sections event date: was inadvertently omitted on the initial report and is provided within this follow up report.

• Brand Name: ECARECOORDINATOR
• Type of Device: ECARECOORDINATOR
• Manufacturer (Section D): PHILIPS VISICU; 217 e. redwood st.; suite 1900; baltimore MD 21202 1970
• Manufacturer (Section G): PHILIPS VISICU; 217 e. redwood st.; suite 1900; baltimore MD 21202
• Manufacturer Contact: cathleen hargreaves ; 217 e. redwood st.; baltimore, MD 21202 ; 4108434690
• MDR Report Key: 5143888
• MDR Text Key: 28463239
• Report Number: 1125873-2015-00018
• 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: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45356456091
• Other Device ID Number: V.1.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2015
• 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: 1125873-08-24-15-019-C
• Patient Sequence Number: 1