MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK EKG MACHINE - TAG ID GR0053672; ELECTROCARDIOGRAPH

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 03/25/2022

Event Type  malfunction  

Event Description

As we were placing ekg leads on patient.Patient jumped and stated that the ekg shocked him.Patient took a deep breath and did not complain of any pain after incident.No burns or other injuries noted at time of incident.Fda safety report id # (b)(4).

• Brand Name: MIDMARK EKG MACHINE - TAG ID GR0053672
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MIDMARK CORPORATION
• MDR Report Key: 13995667
• MDR Text Key: 288652382
• Report Number: MW5108728
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/30/2022

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 Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Male