MAUDE Adverse Event Report: VISICU, INC - DUP ECARECOMPANION; ECAD BP MEDIUM/LG

Model Number 453564551731

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 01/27/2017

Event Type  malfunction  

Event Description

Investigation showed that patient's last measurement was the 29th.Cuff size was correct for the device.Per the hha, the device appeared to overinflate.Patient is currently pending removal of devices.Patient was on service for 9 days prior to incident.

Manufacturer Narrative

Philips q&r has completed the investigation for the reported failure of a patient injured with the ecare companion blood pressure (bp) cuff device.The device was returned to the 3rd party logistics supplier (3pl) (b)(4) on march 9, 2017.The bp cuff passed all tests with appropriate readings.This complaint could not be confirmed.Q&r will continue to monitor for trends.

• Brand Name: ECARECOMPANION
• Type of Device: ECAD BP MEDIUM/LG
• Manufacturer (Section D): VISICU, INC - DUP; 217 e redwood st ste 1900; baltimore MD 21202
• Manufacturer (Section G): VISICU, INC.; 217 e redwood st ste 1900; baltimore MD 21202
• Manufacturer Contact: justin minor ; 217 e redwood st ste 1900; baltimore, MD 21202
• MDR Report Key: 6345784
• MDR Text Key: 68276045
• Report Number: 1125873-2017-00003
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/30/2017

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: Lay User/Patient
• Device Model Number: 453564551731
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR