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U.S. Department of Health and Human Services

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

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VISICU, INC - DUP ECARECOMPANION ECAD BP MEDIUM/LG Back to Search Results
Model Number 453564551731
Device Problem Inflation Problem (1310)
Patient Problem Ecchymosis (1818)
Event Type  Injury  
Event Description
Investigation revealed that the bruising was present after the readings were taken, not prior. Per hha cuff appeared to be overinflating. Transmission stopped on the (b)(6) after 12 days of service. Customer is currently being removed from service.
 
Manufacturer Narrative
Philips q&r has completed the investigation for the reported failure of an ecare companion blood pressure (bp) cuff device overinflating and causing bruising. The device was returned to the 3rd party logistics supplier (3pl) iqor on (b)(6) 2017. The bp cuff passed all tests with appropriate readings. This complaint could not be confirmed. Q&r will continue to monitor for trends.
 
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Brand NameECARECOMPANION
Type of DeviceECAD 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 Key6345781
MDR Text Key67852139
Report Number1125873-2017-00002
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043217
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 01/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number453564551731
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/30/2017
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 Unkown

Patient Treatment Data
Date Received: 02/21/2017 Patient Sequence Number: 1
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