MAUDE Adverse Event Report: MORTARA INSTRUMENT ELI380 ERGO WAM WLAN USB DICOM SEC AHA B ELECTROCARDIOGRAPH

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).

• 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
• Manufacturer Contact: lori daulton ; 1069 state route 46 east; batesville, IN 47006 ; 8129312280
• MDR Report Key: 10364945
• MDR Text Key: 201664038
• Report Number: 2183461-2020-00001
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: USER FACILITY

Reporter Occupation

• 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

• Date FDA Received: 08/04/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: NO INFORMATION
• Device MODEL Number: ELI380-DCS11
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 07/29/2020
• 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: Invalid Data

Patient TREATMENT DATA

Date Received: 08/04/2020 Patient Sequence Number: 1