MAUDE Adverse Event Report: PHILIPS VISICU ECARECOORDINATOR

Model Number 453564506091

Device Problems Failure to Fire (2610); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2015

Event Type  malfunction  

Manufacturer Narrative

Initial investigation in the event identified the following: the patient was only taking weight measurements once a week.Week 1, the patient submitted a weight measurement of (b)(6) and on the second week (7 days later) the patient submitted a weight measurement of (b)(6) and no flag was generated.The patient did not suffer from serious injury nor was intervention taken.The patient had 8 rules configured by the health facility for the them.Only one rule looked for weight increase of that number of days: rule 4: if the maximum change over the last 8 days has increased by more than 7.9 lbs then set a flag of high severity.Investigation determined that the weight gain did not flag due to the requirement that states "if the x number of days specified in the intervention rule exists from the current episode start date to today, evaluate the measurement".As there were only 7 days on the episode and the intervention rule triggers at 8, the measurement did not flag.

Event Description

Customer reported to philips visicu that the patient weight values are outside trigger bounds but the weight change was not triggered/flagged.The patient did not suffer from serious injury nor was intervention taken.

Manufacturer Narrative

Engineering has developed a corrective action associated with this issue.The corrective action is being deployed to the affected 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: 5091656
• MDR Text Key: 26501751
• Report Number: 1125873-2015-00016
• 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: company representative,health
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Followup
• Report Date: 08/24/2015,11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 453564506091
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Report to Manufacturer: 08/24/2015
• 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
• Patient Outcome(s): Disability