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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT PRESSURE CONTROLLER KIT NON-INVASIVE CLEARSIGHT PRESSURE CONTROLLER

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EDWARDS LIFESCIENCES CLEARSIGHT PRESSURE CONTROLLER KIT NON-INVASIVE CLEARSIGHT PRESSURE CONTROLLER Back to Search Results
Model Number PC2K
Device Problem Incorrect Measurement (1383)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/20/2016
Event Type  malfunction  
Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received. Upon return of the product a supplemental report will be submitted with the investigation results. The device service history record review was completed and documented that the device met all specifications upon distribution.
 
Event Description
It was reported that while monitoring a patient during a neck surgery, there was a blood pressure reading discrepancy. There was a difference of 20 ¿ 30mmhg between the clearsight system and the nibp (non-invasive blood pressure). The patient also had an arterial line with a flotrac which correlated with the nibp. When the discrepancy was observed with the clearsight system, the clinician discontinued use of the system. There was no patient harm or injury.
 
Manufacturer Narrative
One pressure controller was received for product evaluation. The examination found that when the pressure controller was connected to a good working clearsight system, that there were no errors observed. The blood pressure readings that were displayed were normal readings. The fct1 and fct2 calibration tests were performed and the product passed both tests. There were no issues noted. The device service history record review was completed and all manufacturing inspections passed with no non-conformances. The reported issue was not confirmed by evaluation. There was no defect found. There are no indications that this is related to the manufacturing process. It could not be determined if any clinical or procedural factors may have contributed to the event. No further actions will be taken at this time.
 
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Brand NameCLEARSIGHT PRESSURE CONTROLLER KIT
Type of DeviceNON-INVASIVE CLEARSIGHT PRESSURE CONTROLLER
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer Contact
lynn selawski
1 edwards way
irvine, CA 92614
9497564386
MDR Report Key5778615
MDR Text Key49054447
Report Number2015691-2016-02166
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 company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 06/20/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/19/2019
Device Model NumberPC2K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/20/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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