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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

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.Company rep was contacted and alternate product to be trialed.Fda safety report id# (b)(4).

• Brand Name: EKG PATCHES
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 11385035
• MDR Text Key: 234042492
• Report Number: MW5099654
• Device Sequence Number: 1
• Product Code: DRX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR