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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MORTARA INSTRUMENT ELI380 ERGO WAM WLAN USB DICOM SEC AHA B; ELECTROCARDIOGRAPH
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MORTARA INSTRUMENT ELI380 ERGO WAM WLAN USB DICOM SEC AHA B; ELECTROCARDIOGRAPH Back to Search Results
Model Number ELI380-DCS11
Device Problem Wireless Communication Problem (3283)
Patient Problems Death (1802); Myocardial Infarction (1969)
Event Type  Death  
Manufacturer Narrative
The customer alleged the eli 380 connection failed and the device would not download the patient worklist.A connection failed message indicates that the device is unable to transmit or receive ekg¿s, this includes downloading of a worklist.The eli 380 offers a stat function which allows the user to obtain an ekg in an emergent situation.It was not reported that the stat ekg option was utilized during the rapid response at the bedside.It is common that during a rapid response, multiple healthcare professionals (physicians, nurses, respiratory therapists) respond to provide immediate intervention.Utilizing the stat ekg function and having a physician at the bedside would allow for the opportunity to recognize an abnormal ekg reading immediately.This would prevent a delay in diagnosis/treatment.Based on the information provided that the stat ekg function was not reportedly utilized, hillrom is conservatively reporting this death due to a user error.No further information is available on the investigation of the ecg device.Hillrom has requested the device to be returned by the customer.The investigation is ongoing.If any additional relevant information is identified following return of the device and completion of the device evaluation, the additional relevant information will be submitted in a supplemental report.Based on this information, no further action is required at this time.
 
Event Description
Hillrom received a report from the account stating a patient experienced a rapid response which required an ekg at 12:06.During the ekg, the device had a connection failed message.The patient was then transferred to the icu at 12:18 where an ekg was performed and identified a stemi.The patient later expired.The date and cause of death were not reported.This report was filed in our complaint handling system as complaint # (b)(4).
 
Event Description
Hillrom received a report from the account stating a patient experienced a rapid response which required an ekg at 12:06.During the ekg, the device had a connection failed message.The patient was then transferred to the icu at 12:18 where an ekg was performed and identified a stemi.The patient later expired.The date and cause of death were not reported.This report was filed in our complaint handling system as complaint (b)(4).
 
Manufacturer Narrative
The customer alleged the device displayed a connection failed message which indicates that the device is unable to transmit or receive ekg¿s, including downloading a worklist.Due to the failed connection, there may have been a delay in diagnosing the stemi which may have caused or contributed to the patient's death.Based on this additional information provided to hillrom, hillrom is conservatively reporting this death due to the connection failure as a product malfunction.Based on this information, no further action is required at this time.
 
Event Description
Hillrom received a report from the account stating a patient experienced a rapid response which required an ekg at 12:06.During the ekg, the device had a connection failed message.The patient was then transferred to the icu at 12:18 where an ekg was performed and identified a stemi.The patient later expired.The date and cause of death were not reported.This report was filed in our complaint handling system as complaint#: (b)(4).
 
Manufacturer Narrative
It was determined the radio module used in eli380 v2.4.2, is affected by an issue in presence of cisco ccx wi-fi frames.Specifically, when a cisco ccx rm (resource management) frame is sent by cisco access point and received by eli380 wi-fi module, the atheros radio module firmware can crash, leading to a disconnection from wi-fi network.While at times newmar wi-fi module fw can recover from this condition, at other times it cannot, leading to permanent disconnection from wi-fi network and in rarer cases to a complete inability for the newmar wi-fi module to communicate with eli380.In these situations a reboot of the newmar module is required, to be performed by the operator through reboot of eli380 or by saving the wi-fi configuration again.The issue will be resolved with validation and release of a new software for eli380 v2.5.0.
 
Event Description
Hillrom received a report from the account stating a patient experienced a rapid response which required an ekg at 12:06.During the ekg, the device had a connection failed message.The patient was then transferred to the icu at 12:18 where an ekg was performed and identified a stemi.The patient later expired.The date and cause of death were not reported.This report was filed in our complaint handling system as complaint #(b)(4).
 
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Brand Name
ELI380 ERGO WAM WLAN USB DICOM SEC AHA B
Type of Device
ELECTROCARDIOGRAPH
Manufacturer (Section D)
MORTARA INSTRUMENT
7865 n 86th street
milwaukee WI 53224
MDR Report Key10364945
MDR Text Key201664038
Report Number2183461-2020-00001
Device Sequence Number1
Product Code DPS
UDI-Device Identifier00812345026917
UDI-Public812345026917
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup,Followup,Followup
Report Date 08/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberELI380-DCS11
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/29/2020
Initial Date FDA Received08/04/2020
Supplement Dates Manufacturer Received07/29/2020
07/29/2020
07/29/2020
Supplement Dates FDA Received08/05/2020
09/24/2020
11/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
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