MAUDE Adverse Event Report: MORTARA INSTRUMENTS INC. ELI 280; ELECTROCARDIOGRAPH

Model Number ELI 280

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2017

Event Type  malfunction  

Event Description

We have 5 motara ekg carts and we have had these for 3 years and 4 months.All 5 had issues with the touch screen.It is difficult to get the cart to acknowledge when you have touched something on the display.Manufacturer response for ekg cart, mortara (per site reporter).They feel that maybe staff is using a pen or some foreign object on the touch screen, but there are no visual markings on the touch screens.

• Brand Name: ELI 280
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENTS INC.; 7865 north 86th street; milwaukee WI 53224
• MDR Report Key: 6914010
• MDR Text Key: 88160382
• Report Number: 6914010
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/22/2017

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 Operator: Other
• Device Model Number: ELI 280
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2017
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; TO DO A 12 LEAD EKG ON A PATIENT