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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES EV1000 PUMP UNIT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number EVPMP
Device Problems Material Discolored (1170); Incorrect Measurement (1383)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 05/10/2019
Event Type  malfunction  
Manufacturer Narrative
The device was returned for evaluation. During the evaluation, the pump unit failed the functional testing. It failed the ¿sequence: verify pressure¿ at various flows. The output pressure failed, as the measurement was 325. 0735 mmhg with limits of low: 337 and high: 350. The test technician found that the screws holding the relief valve were raised up from the manifold bottom. All tests passed after the manifold bottom was replaced. The housing damage was due to customer induced damage and the test failure was due to hardware failure. A device history record review was completed and documented that the device met all specifications upon distribution. An engineering evaluation was initiated and completed to assess for any manufacturing-related processes which could be correlated to the complaint. No manufacturing non-conformances were found. With any hemodynamic monitoring, pressure readings can change quickly and dramatically. Pressure readings should correlate with the patient¿s clinical manifestations. These devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise. These devices are typically used in intensive care units or operating rooms where patients are closely monitored. In this event the pump unit failed the pressure output functional test and fell below the lower limits. No patient was involved. 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 a part of the monthly review.
 
Event Description
As reported, during a preventive maintenance by edwards technical services, the unit housing of this pump unit was discolored and had a yellow stain. The unit will be returned to the manufacturer to replace the housing. There was no patient involved. The device was available for evaluation. During the evaluation, it was found that the pump unit failed the functional testing for output pressure.
 
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Brand NameEV1000 PUMP UNIT
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
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 Key8833768
MDR Text Key152669126
Report Number2015691-2019-02782
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K140312
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/01/2019
Device Model NumberEVPMP
Device Catalogue NumberEVPMP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2019
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 Manufactured09/01/2014
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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