MAUDE Adverse Event Report: MORTARA INSTRUMENT EXCH 380 TOUCH W/ENGLISH KEYBD, LAIRD; ELECTROCARDIOGRAPH

Model Number SERV RELI380L-P-D

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2024

Event Type  malfunction  

Manufacturer Narrative

The eli 380 is intended to be a high-performance, multichannel resting electrocardiograph.As a resting electrocardiograph, the eli 380 simultaneously acquires data from each lead.Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted.It is a device primarily intended for use in hospitals but may be used in medical clinics and offices of any size.Device is indicated for use to provide interpretation of the data for consideration by a physician.Device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician.It is not intended as a sole means of diagnosis.The interpretations of ecg offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.Device is indicated for use on adult and pediatric populations.The device is not intended to be used as a vital signs physiological monitor.The device was returned for repair where during inspection, the hrc technician noted that the issue was with the keyboard.The technician replaced the burnt keyboard and housing along with the printer to resolve and performed functional testing on the unit.The repaired unit will be returned to the customer.Based on this information, no further actions are necessary at this time.Although there was no injury reported as a result of this incident, if the unit were to catch fire during use, it could lead to a serious injury or death.Therefore, hillrom is reporting this malfunction.

Event Description

The customer reported that the eli 380 caught fire due to the ribbon cable from motherboard to touch screen.There was no patient involvement reported.This incident was captured under hillrom complaint # (b)(4).

• Brand Name: EXCH 380 TOUCH W/ENGLISH KEYBD, LAIRD
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18886797
• MDR Text Key: 337485996
• Report Number: 2183461-2024-00005
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00732094326291
• UDI-Public: 732094326291
• 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: Other
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SERV RELI380L-P-D
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1