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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bruise/Contusion (1754)
Event Type  Injury  
Manufacturer Narrative
Philips h2h q&r has completed the investigation for the report of a bp cuff causing bruising after use. The device was not returned for investigation so testing on this specific device was not possible. However, the vendor (a&d) previously investigated bp cuffs of the same product family that caused bruising after use. A&d conducted a maximum inflation level test since over-inflation is the most common cause of arm bruising during/after use. The returned devices stopped inflation at 299 mmhg and met the safety design requirement of 300 mmhg. The inflation level of the bp measurement depends on the patient¿s hypertensive condition. The bp cuff will inflate higher if the patient is more hypertensive and lower if the patient is less hypertensive. Higher pressure generated by the device will result in a tighter obstruction, whereas lower pressure will result in a looser obstruction. Thus, a tighter obstruction may lead to a higher change of skin bruising and feeling discomfort or a resulting bruise is possible for hypertension patients. The patient who reported this incident¿s hypertensive condition is unknown. This complaint is confirmed for bruising but not confirmed for a device malfunction as the device was not returned for investigation. H2h q&r will continue to monitor for trends.
 
Event Description
Customer reported that the bp cuff caused bruising on a patient after use.
 
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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)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
sarah aultowski
217 e redwood st ste 1900
baltimore, MD 21202
MDR Report Key6760954
MDR Text Key192897571
Report Number1125873-2017-00006
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 07/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number453564551731
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/02/2017 Patient Sequence Number: 1
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