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Model Number 194371001
Device Problem Sparking (2595)
Patient Problem No Patient Involvement (2645)
Event Date 05/01/2017
Event Type  malfunction  
Manufacturer Narrative
The reported issue of a spark from the power cord is consistent with excessive and/or repeated flexing and twisting of the power cord. Over time this will cause damage to the internal wires and cause an intermittent or open connection. The open connection will cause inconsistent delivery of power and potential for spikes in voltage. As there is no lot or serial number for this product as it is included and packaged as part of the ev1000ni assembly; the manufacturing records cannot be reviewed and the device history record review could not be completed. However, the issue is not consistent with a manufacturing defect. The primary root cause is flexing and twisting of the cable by the customer. This power cord/plug was tested and is acceptable to united states standards ul 817. This rating is an industry standard for hospital-grade power cords/plug. An intermittent spark does not have the energy needed to burn through the plastic connector or ignite the material and be exposed to the clinical environment. In addition, the spark occurred inside the connector and was contained within flammability-rated material. There is no further action to be taken at this time.
Manufacturer Narrative
The product has been returned for evaluation; however, the evaluation has not been completed. Once the evaluation is completed, a supplemental report will be submitted with the evaluation results.
Event Description
It was reported that while the clinicians were setting up prior to a procedure, they plugged in an edwards 110v power cord into a pump unit and they observed a spark from the power cord. They reported that the power cord has physical damage, it is frayed. There was no smoke observed. They removed the power cord from further use. There is no other suspect equipment involved. There was no harm or injury to any hospital personnel. There was no patient involvement.
Manufacturer Narrative
One 110v power cord was received for product evaluation. A visual examination was performed and there was no physical damage observed. There was no fraying that was observed on the cable. The cable was tested and was plugged into a power source and there was no sparking that was seen. A continuity check was performed and it was found that there was an open wire condition on the neutral white wire. The reported event was not confirmed by evaluation; however, an open wire condition was observed. An engineering evaluation is in progress and the results are not available at the time of this submission. When the engineering evaluation and the device service history record review results are available, a supplemental report will be submitted.
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Brand NamePOWER CORD, 110V
Type of DevicePOWER CORD
Manufacturer (Section D)
one edwards way
irvine CA 92614
Manufacturer (Section G)
1 edwards way
irvine CA 92614
Manufacturer Contact
lynn selawski
1 edwards way
irvine, CA 92614
MDR Report Key6577791
MDR Text Key194847576
Report Number2015691-2017-01393
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 05/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number194371001
Device Lot Number5653666
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/11/2017
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