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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL CLEARSIGHT FINGER CUFF SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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CONTRACT MEDICAL INTERNATIONAL CLEARSIGHT FINGER CUFF SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number CSCM
Device Problem False Reading From Device Non-Compliance (1228)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/11/2016
Event Type  malfunction  
Manufacturer Narrative
An investigation was done as a result of the inaccurate blood pressure reading that was received at this event. An edwards rn/bsn visited the facility to further investigate. She provided extensive education and training on the proper use of the products to the bio-medical and nursing staff at the hospital. It was determined that the end user had improperly placed the finger cuff on the patient and therefore, could not obtain an accurate bp reading. She demonstrated the proper set-up and use of the edwards (b)(4) clearsight system. The product will not be returned to edwards for evaluation. The lot number was not provided; therefore, a review of the manufacturing records could not be completed. Please refer to four other submissions for the clearsight units involved; pressure controller, pump unit, (b)(4) unit. Report reference numbers: (b)(4) mfr report# 2015691-2016-00687; (b)(4) mfr report# 2015691-2016-00688; (b)(4) mfr report# 2015691-2016-00689; pump (b)(4) mfr report# 2015691-2016-00690;.
 
Event Description
It was reported that while monitoring a patient with the non-invasive clearsight system the patient's blood pressure reading displayed on the ev1000 monitor above 190 systolic. A manual blood pressure reading was then taken on the upper arm of the patient and the blood pressure reading was around 120 systolic. The physician removed the clearsight system and inserted an arterial line into the patient for monitoring. The patient was not treated with the inaccurate value. There was no patient harm or injury.
 
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Brand NameCLEARSIGHT FINGER CUFF
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
CONTRACT MEDICAL INTERNATIONAL
vazni 848
hradec kralove
500 0 3
EZ 500 03
Manufacturer (Section G)
CONTRACT MEDICAL INTERNATIONAL
vazni 848
hradec kralove
500 0 3
EZ 500 03
Manufacturer Contact
lynn selawski
1 edwards way
irvine, CA 92614
9497564386
MDR Report Key5487351
MDR Text Key40307923
Report Number2015691-2016-00720
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140312
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 02/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCSCM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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