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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000A COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

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EDWARDS LIFESCIENCES EV1000A COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION Back to Search Results
Model Number EV1000A
Device Problem Incorrect Measurement (1383)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2021
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. 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 use in patient of this clearsight, the mean arterial pressure values provided were approximately 10-15mmhg different from the brachial nibp (non-invasive blood pressure). In addition, the clearsight blood pressure values were increasing while those of the nibp were decreasing and vice versa. No error message was displayed and there was no allegation of cuff malfunction. It was unknown whether the brachial nibp was placed on the same arm as the clearsight. There was no allegation of patient harm. Further information including patient demographics were requested but could not be provided.
 
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Brand NameEV1000A
Type of DeviceCOMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer Contact
lynn thomas
1 edwards way
irvine, CA 92614
9497564386
MDR Report Key12211615
MDR Text Key262959848
Report Number2015691-2021-04283
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131892
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 09/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEV1000A
Device Catalogue NumberEV1000A
Device Lot NumberEV055538
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/22/2021 Patient Sequence Number: 1
Treatment
BRACHIAL NIBP
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