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

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.

• Brand Name: CLEARSIGHT FINGER CUFF
• Type of Device: SYSTEM, 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 Key: 5487351
• MDR Text Key: 40307923
• Report Number: 2015691-2016-00720
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSCM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2016
• 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
• Patient Sequence Number: 1