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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES CLEARSIGHT PRESSURE CONTROLER KIT NON-INVASIVE CLEARSIGHT PRESSURE CONTROLLER Back to Search Results
Model Number PC2K
Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 01/25/2019
Event Type  malfunction  
Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received. Upon the return of the product a supplemental report will be sent with the investigation results as well as the device history record. Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
 
Event Description
As reported, during maintenance of this pressure controller kit, the cuff #2 port did not pass functional tests at 200mmhg and 300mmhg. At 200mmhg it measured 128. 20 mmhg (specifications are 197. 8 to 202. 20mmhg) and at 300mmhg it measured 127. 30mmhg (specifications are 297. 8 to 302. 20mmhg). There was no patient involvement. The device was available for further evaluation.
 
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Brand NameCLEARSIGHT PRESSURE CONTROLER KIT
Type of DeviceNON-INVASIVE CLEARSIGHT PRESSURE CONTROLLER
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
samantha eveleigh
one edwards way
irvine, CA 92614
9492503939
MDR Report Key8346395
MDR Text Key137383662
Report Number2015691-2019-00526
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K140312
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 01/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/01/2016
Device Model NumberPC2K
Device Catalogue NumberPC2K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2011
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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