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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000 PUMP UNIT EVPMP

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EDWARDS LIFESCIENCES EV1000 PUMP UNIT EVPMP Back to Search Results
Model Number EVPMP
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/09/2021
Event Type  malfunction  
Manufacturer Narrative
The product has been returned for evaluation. When the product evaluation has been completed, a supplemental report will be submitted. The device history record review was completed and all inspections passed with no non-comformances.
 
Event Description
The pump unit failed functional test for pressure at various flows with the difference pressure outlet ad at 150 normal liters per hour. The measurement is 136. 3 mmhg and the limits are from plus or minus 10 mmhg. The test technician found that the pumps manifold bottom had cracks around the pems for the manifold lid. All tests passed after the manifold bottom was replaced. There were no error messages or alarms that displayed. There was no patient involvement.
 
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Brand NameEV1000 PUMP UNIT
Type of DeviceEVPMP
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer Contact
jessica atallah
one edwards way
irvine, CA 92614
9492500294
MDR Report Key12579949
MDR Text Key275002030
Report Number2015691-2021-05526
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140312
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEVPMP
Device Catalogue NumberEVPMP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2018
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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