MAUDE Adverse Event Report: MORTARA INSTRUMENT, INC. BURKICK ELI 280; ELECTROCARDIOGRAPH (EKG)

Model Number ELI280

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Burn(s) (1757); Tingling (2171); Electric Shock (2554)

Event Date 09/14/2017

Event Type  malfunction  

Event Description

Nurse was hooking up leads and wires of ekg to pt.As the nurse put a wire to a lead, the wire went across the pt's chest and the pt said she felt something burning her.Pt asked the nurse what it was and nurse told her she did not know because the (ekg) machine was not on.Pt stated it was like an electrical shock.Pt states she got home and had some tingling and found a pad left on her chest, that is when she found what looks like a burn on her chest.

• Brand Name: BURKICK ELI 280
• Type of Device: ELECTROCARDIOGRAPH (EKG)
• Manufacturer (Section D): MORTARA INSTRUMENT, INC.; milwaukee WI
• MDR Report Key: 6979148
• MDR Text Key: 90411118
• Report Number: MW5072947
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ELI280
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 128