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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000 NI PUMP UNIT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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EDWARDS LIFESCIENCES EV1000 NI PUMP UNIT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number EVPMP
Device Problem Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2021
Event Type  malfunction  
Manufacturer Narrative
The pump unit was repaired by the hospital and there have been no issues since the repair; however, edwards is following-up to get the unit returned for evaluation. The device service history record review was completed and all manufacturing inspections passed with no non-conformances.
 
Event Description
As reported, smoke from the power socket of the pump unit was observed, at the beginning of the procedure with this pump unit as part of an ev1000ni system. No sparks nor fire were reported. Battery symbol was flicking on and off on the screen power display; however, monitor stayed on and the information also stayed. The device was replaced immediately when the issue was noticed. The appropriate cover was installed on the power cable socket of the pump unit. The used power cable was not an edwards device. The iec connector on the power appeared to have a dark build up at the neutral terminal (most likely melted plastic from the iec connector) and therefore, there was also dark build up on the neutral pin of the pump unit. There was no allegation of patient injury nor of the staff.
 
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Brand NameEV1000 NI PUMP UNIT
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer Contact
samantha eveleigh
1 edwards way
irvine, CA 92614
9492503939
MDR Report Key12622553
MDR Text Key276101148
Report Number2015691-2021-05647
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 Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberEVPMP
Device Catalogue NumberEVPMP
Device Lot Number600153016843
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/02/2020
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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