MAUDE Adverse Event Report: CARDINAL HEALTH / CARDINAL HEALTH 200, LLC EKG PATCHES; ELECTRODE, ELECTROCARDIOGRAPH

Lot Number 191114K

Device Problems Pacing Inadequately (1442); Defective Component (2292)

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

Event Date 02/05/2021

Event Type  No Answer Provided  

Event Description

New ekg patches provided to the lab were used during a sterile procedure.They were not adequately showing ekg.Staff had to enter sterile field, risking contamination, to replace all ekg patches to properly monitor the patient.This has been reported to the manufacturer.Fda safety report id# (b)(4).

• Brand Name: EKG PATCHES
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CARDINAL HEALTH / CARDINAL HEALTH 200, LLC
• MDR Report Key: 11385162
• MDR Text Key: 234116131
• Report Number: MW5099664
• Device Sequence Number: 1
• Product Code: DRX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 191114K
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 82 YR