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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 06/17/2016
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be evaluated; however, at the time of this report, the device has not been returned. A supplemental report will be submitted to communicate the results of the complaint investigation results. The ev1000 pump unit was also submitted and the mdr number is 2015691-2016-02233.
 
Event Description
It was reported, that during the first day of use, of an ev1000 pump unit the clearsight measurements were 110-120/80-90 while the nibp (non-invasive blood pressure) were 150/65. On the second day of use the clearsight measurement were 93/56 compared to the nibp of 126/56. The hrs was replaced but the problem persisted. The patient was not treated based on the inaccurate clearsight values. No patient compromise was reported. Two devices were implicated in this event; one for the ev1000 pump unit and one for the ev1000 pressure controller.
 
Manufacturer Narrative
The device history record review was completed and all manufacturing inspections passed with no non-conformances. Examination of the returned device was unable to replicate the customer¿s complaint. However, another incident was identified; the cuff 1 connector was pushed back on one side, pins 10 and 12 have lifted solder pads and pin 11 has a fractured solder joint. This may be attributed to user handling. No further actions are required at this time. Edwards will continue to review and monitor all events. If action is required, an appropriate investigation will be performed.
 
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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 Key5796849
MDR Text Key49627374
Report Number2015691-2016-02234
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K140312
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
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 Received07/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPC2K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/28/2015
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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