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Model Number EVPMP
Device Problems Thermal Decomposition of Device (1071); Fire (1245); Explosion (4006)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/21/2018
Event Type  malfunction  
Manufacturer Narrative
The suspect pump unit was returned to the local service center for evaluation. The customer's complaint was confirmed as the power connection and power cord were burnt. The device is being sent directly to the manufacturer for further evaluation. At this time the root cause was unable to be identified. A supplemental report will be provided when the additional evaluation is completed. The design history record is in process and the results will be communicated in a follow-up report. Fires, especially in oxygen rich environments have the potential to injure a patient or the user. In this instance, there was an explosion and then fire was observed. There was no harm to the patient or user. In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise. It is unknown if user or procedural factors could have contributed to this event. 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 with a patient using this ev1000 pump unit, after connecting the ev1000 monitor with a volumeview set to the patient and starting the measurements, the hospital¿s electrical alarm network was heard just after getting numbers on the monitor. The electrical department was called to investigate. At that time, an explosion on the pump unit was heard and there was fire from the pump unit. The ev1000 monitor was immediately disconnected from the main power supply and the system alarm stopped. Another ev1000 system was used to reconnect the volumeview already placed in the patient and everything worked. There was no allegation of patient injury. The device was available for evaluation.
Manufacturer Narrative
Our product evaluation laboratory received the ev1000 pump unit. The pump unit's power connection and power cord smelled burned and appeared burned. The device was sent to the manufacturer for further investigation. An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint. The device history record review is in process but hasn't been completed. Once the results are available, a supplemental report will be submitted.
Manufacturer Narrative
A device history record review was completed and documented that the device met all specifications upon distribution.
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Brand NameEV1000 PUMP UNIT
Type of DeviceEVPMP
Manufacturer (Section D)
one edwards way
irvine CA 92614
Manufacturer (Section G)
one edwards way
irvine CA 92614
Manufacturer Contact
samantha eveleigh
1 edwards way
irvine, CA 92614
MDR Report Key8167213
MDR Text Key130978587
Report Number2015691-2018-05308
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeSI
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 11/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/01/2020
Device Model NumberEVPMP
Device Catalogue NumberEVPMP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2018
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 Manufactured11/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse