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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000 CLINICAL PLATFORM NON-INVASIVE (NI) OR CLEARSIGHT SYSTEM SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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EDWARDS LIFESCIENCES EV1000 CLINICAL PLATFORM NON-INVASIVE (NI) OR CLEARSIGHT SYSTEM SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number PC2K
Device Problem Incorrect Measurement (1383)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/25/2021
Event Type  malfunction  
Manufacturer Narrative
A complete product evaluation and an engineering investigation will be performed in order to consider any potential factor that may have contributed to this complaint.
 
Event Description
As reported, during the preventive maintenance of this pressure controller kit (pc2k), the measurements at cuff port 1 were not in range for the test at 300mmhg, as the values provided were toggling between 255 and 265 mmhg. There was of error message displayed during this test. There are no patient demographics available since there was no patient involved. This device was available for evaluation.
 
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Brand NameEV1000 CLINICAL PLATFORM NON-INVASIVE (NI) OR CLEARSIGHT SYSTEM
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer Contact
samantha eveleigh
1 edwards way
irvine, CA 92614
9492503939
MDR Report Key12173677
MDR Text Key261709023
Report Number2015691-2021-04108
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K203131
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/20/2020
Device Model NumberPC2K
Device Catalogue NumberPC2K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2015
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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