ELI 380 ELI380

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-28 for ELI 380 ELI380 manufactured by Mortara Instrument, Inc..

Event Text Entries

[101175976]
Patient Sequence No: 1, Text Type: N, H10


[101175977] While attempting to perform an ecg the nurse activated the wireless access module (wam), the device would not connect with the mortara eli380 ecg machine. Another machine was used with the same result (different wam module also. Staff changed batteries, attempted to use the other wam modules to see if they had gotten mixed up - it did not work. Staff called for another machine and the ecg was performed after a short delay, no patient harm. Manufacturer response for ecg machine, mortara (per site reporter) discussed with service technician issue was likely related to electrical interference of some type, which probably resolved by the time the other machine, arrived. Could not duplicate the issue. We have ordered a back-up hard wired trunk cable to use in case of future issues with the wireless module to minimize delay time to diagnostic ecg.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7302142
MDR Report Key7302142
Date Received2018-02-28
Date of Report2018-02-23
Date of Event2018-02-23
Report Date2018-02-23
Date Reported to FDA2018-02-23
Date Reported to Mfgr2018-02-23
Date Added to Maude2018-02-28
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameELI 380
Generic NameELECTROCARDIOGRAPH
Product CodeDPS
Date Received2018-02-28
Model NumberELI380
OperatorNURSE
Device AvailabilityY
Device Age1 YR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMORTARA INSTRUMENT, INC.
Manufacturer Address7865 N 86TH. ST MILWAUKEE WI 53224 US 53224


Patients

Patient NumberTreatmentOutcomeDate
10 2018-02-28

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