MAUDE Adverse Event Report: PHILIPS VISICU ECARECOORDINATOR

Model Number 45356456091

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Weight Changes (2607)

Event Date 10/29/2015

Event Type  Injury  

Manufacturer Narrative

Investigation identified that the issue reported is associated defect in which the device logic looks back 7 days inclusive of today and gets the minimum and the maximum value from those past measurements.The device logic then compares the date of the maximum and minimum value to determine if it is an increase or decrease within the timeframe.Patient's weight measurements ranged from (b)(6).Over a 7 day period.The device only flagged for the weight loss, not the weight gain.The patient was hospitalized due to the weight gain.The 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 of measurements works similarly, it evaluates the smallest value and largest value over a number of defines 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 larger weight loss and smaller weight gain, only the weight loss met the requirements and the weight loss was flagged.Engineering developed a corrective action for this defect and is being deployed to affected customers.The defect is corrected in v.1.3.

Event Description

The customer stated that the device flagged the patient as having lost 4.9 lb in one week.However, the patient actually gained 5.4lb in 5 days.Patient was hospitalized for weight gain due to condition(heart failure).Patient condition is unknown.

Event Description

Philips clinical team was informed by the customer that the patient was discharged from the hospital after a stay from (b)(6) 2015.Patient has returned to the home monitoring program.Patient seems to be doing fine.

• 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; suite 1900; baltimore MD 21202
• Manufacturer Contact: cathleen hargreaves ; 217 e. redwood st.; suite 1900; balitmore, MD 21202 ; 4108434690
• MDR Report Key: 5247178
• MDR Text Key: 32057994
• Report Number: 1125873-2015-00026
• 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: 11/05/2015,12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• 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 Report to Manufacturer: 11/05/2015
• Initial Date Manufacturer Received: 11/05/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/17/2015
• 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: 1125873-08-06-15-014-C
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 91 YR
• Patient Weight: 92