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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT PRESSURE CONTROLLER KIT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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EDWARDS LIFESCIENCES CLEARSIGHT PRESSURE CONTROLLER KIT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number PC2K
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2017
Event Type  malfunction  
Manufacturer Narrative
Review of the device history record supports that there were no non-conformances noted for any reason during the manufacturing of the referenced device and no prior service history for any reason. During examination of the returned device, the cuff 1 connector showed physical damage and open solder joints consistent with field damage. There was no evidence or indication that the damage was the result of any manufacturing defect. The heart reference sensor zeroed appropriately and was able to obtain stable readings when the cuff was not moved. However, any pressure applied to the cuff resulted in the measurements stopping - the readings were not erratic and did not fluctuate. Additionally, cuff 2 obtained normal bp readings 3 times without any issues.
 
Event Description
It was reported that while using the ev1000 in clearsight-mode, after successfully calibrating and zeroing the device according to the dfu, the pressure controller displayed erratic systolic, diastolic and mean arterial parameters. Additionally, the monitor would stop working and required restarting by pushing the clearsight start button. No alarm/error messages were observed on the monitor. To troubleshoot the issue, the system was restarted. However, the cuff was not recognized in port 1 so it was changed to port 2, where it was recognized. The patient was not treated according the suspect values and there was no report of any patient compromise for any reason. The heart reference sensor and the pressure controller were replaced to resolve the issue. The monitor subsequently displayed uninterrupted expected values. Partial patient demographics were provided; additional information regarding patient demographics was not available.
 
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Brand NameCLEARSIGHT PRESSURE CONTROLLER KIT
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
one edwards way
irvine CA 92614
Manufacturer Contact
lynn selawski
1 edwards way
irvine, CA 92614
9497564386
MDR Report Key6720465
MDR Text Key80335510
Report Number2015691-2017-02085
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K140312
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 06/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2021
Device Model NumberPC2K
Device Catalogue NumberPC2K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/04/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/17/2017 Patient Sequence Number: 1
Treatment
MONITOR, HRS
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