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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000 POWER ADAPTER

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EDWARDS LIFESCIENCES EV1000 POWER ADAPTER Back to Search Results
Model Number EVPSB220L
Device Problems Moisture Damage (1405); Smoking (1585); Electrical Power Problem (2925); Appropriate Term/Code Not Available (3191)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 02/04/2019
Event Type  malfunction  
Manufacturer Narrative
The product was not returned for analysis. Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor can a root cause or any potential contributing factors be identified. The device history record review could not be performed as the serial number is unknown. An engineering evaluation was completed to determine if any manufacturing non-conformances were involved in this issue. The device was not returned, but the reported issue is largely consistent with liquid ingress into the power supply. Smoke was seen but no fire resulted. This complaint was not confirmed as the power supply was not returned, however it was reported that there was smoke after fluid fell onto the power supply and that it was burnt. A complaint of smoke could result in a fire. In this instance there was no fire and no harm to a patient or user. 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 of this ev1000 system, the power supply was burned. There was no allegation of patient injury. As per follow up, it was communicated that there was smoke and that fluid had fallen on the device. There was no consequence for the clinical staff. The mounting bracket was properly connected. The power supply will not be returned for evaluation.
 
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Brand NameEV1000 POWER ADAPTER
Type of DeviceEV1000 POWER ADAPTER
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 Key8412847
MDR Text Key138956550
Report Number2015691-2019-00829
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeBR
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 02/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEVPSB220L
Was Device Available for Evaluation? No
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
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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