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MORTARA INSTRUMENT, INC. ELI380 Back to Search Results
Model Number ELI380-ACX11
Device Problems Nonstandard Device (1420); Patient Data Problem (3197)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/21/2015
Event Type  Malfunction  
Event Description

Customer reported a specific pt ecg could not be located in their emr system. They located the printed record with the correct pt info written to the record. They searched their emr system for the acquisition time of the record and found a different pt's demographic info attached to the same waveform of the actual pt. This has been observed four times on two different eli380 carts/ the customer manually located the mismatched records, corrected the demographic info, and saved the records. No pt injury or misdiagnoses was reported.

Manufacturer Narrative

(b)(4) was opened to document investigation and corrective action for this issue. Mortara instrument, inc has recently become aware of a potential safety hazard involving our eli 380 electrocardiograph. When used in the workflow described below, acquired ecg waveforms for one pt may become associated with the pt demographics for a different pt when the record is transmitted to a records management system. A hazardous situation may be created when the following workflow is used: ecgs are ordered via an external records management system. An order list is downloaded to the eli 380 electrocardiograph. An ecg technician selects an order from the list in the eli 380, locates the pt, acquires and stores the ecg record on the eli 380. A new order list is subsequently downloaded to the same eli 380 and the new order list differs from the previous order list. An ecg associated with the original order list is retrieved from memory, edited and stored again. The ecg record is transmitted to the records management system to fulfill the order. In this workflow, editing and saving the record in step 5 may result in a wrong order number becoming associated with the ecg record in the eli 380. When the ecg record is transmitted to the records management system to fulfill the order, the incorrect order number may cause the receiving system to associate the acquired ecg waveforms with the wrong pt demographics. Thus, when viewed on the records management system, the ecg may show the demographics for pt a, but the ecg waveforms for pt b. This problem only occurs when using the eli 380 in an orders-driven environment. Records with mismatched ecg waveforms and pt demographics only appear on the records management system after being received from the eli 380. When viewed or printed on the eli 380 itself, ecg waveforms and pt demographics are always matched properly. A correction has been developed to eliminate the identified potential risk. The correction requires the eli 380 system software to be upgraded to version 1. 1. 1. This new version of software corrects the handling of order numbers to ensure the correct order number is associated with the correct ecg, regardless of the workflow.

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Brand NameELI380
Type of DeviceELI380
Manufacturer (Section D)
7865 north 86th st.
milwaukee WI 53224
Manufacturer Contact
tim field, svp qly
7865 north 86th st.
milwaukee, WI 53224
MDR Report Key4835052
MDR Text Key15911978
Report Number2183461-2015-00002
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK142105
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User facility
Remedial Action Recall
Type of Report Initial
Report Date 06/01/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/01/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device MODEL NumberELI380-ACX11
Device Catalogue NumberELI380-ACX11
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/22/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/26/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction Number2183461-05/27/15-001-C