MAUDE Adverse Event Report: MORTARA INSTRUMENT ELI280 NOACQMOD NOPTCBL WLAN USBD; ELECTROCARDIOGRAPH

Model Number ELI280-JXX-ADFAX

Device Problem Sparking (2595)

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

Event Date 09/12/2022

Event Type  malfunction  

Event Description

The customer reported "a power outlet sparked when disconnecting an eli-280 from an emergency (red) outlet".There was no harm or injury reported.This event was captured under hill-rom complaint ref # (b)(4).

Manufacturer Narrative

The eli 280 is a 12-lead electrocardiograph device intended to be used to perform 12 lead resting ecgs.The acquired data can be reviewed, stored, printed, and/or transmitted to an emr system.The eli 280 resting electrocardiograph is indicated for use to acquire, analyze, display, and print electrocardiograms.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.For protection against shock, electrically powered welch allyn medical devices are designed, validated and manufactured per the isolation standards in "iec 60601-1".The standard is referenced in the instructions for use.This assures that the mains power is isolated to prevent injury to the patient and user from the mains electrical power.The customer had the device inspected by an in house biomedical technician who subjected the device to an electrical safety test and internal inspection and no faults or indications of burning/overheating were found.The power outlet was inspected and tested and no faults could be found.The only evidence of the event were clear scorch marks on the plug prongs.Hillrom has requested for the device to be returned for analysis but it has not been received.If the device is returned, findings of the investigation will be provided in a follow up report.Although the reported event did not result in a serious injury, the report of a spark when disconnecting the the device's plug from an electrical socket could potentially contribute to a serious injury or death, if the malfunction were to recur.Therefore, hillrom considers this complaint a reportable malfunction.

• Brand Name: ELI280 NOACQMOD NOPTCBL WLAN USBD
• 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: 15578615
• MDR Text Key: 305088392
• Report Number: 2183461-2022-00038
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00732094265712
• UDI-Public: 732094265712
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/11/2022

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: ELI280-JXX-ADFAX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1