MAUDE Adverse Event Report: CARDINAL HEALTH MONITORING ELECTRODE RT SNAP REPOSITIONABLE; ELECTRODE, ELECTROCARDIOGRAPH

Model Number E501RASR

Device Problem Positioning Failure (1158)

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

Event Date 02/03/2021

Event Type  No Answer Provided  

Event Description

Pt arrived for ppm implant.Cardinal rt snap repositionable ekg patches used and ekg quality was undiagnostic, changed out cables and wires applied a second set of cardinal snap repositionable patches and problem persisted.Applied kendall foam patches and artifact resolved.Fda safety report id# (b)(4).

• Brand Name: MONITORING ELECTRODE RT SNAP REPOSITIONABLE
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 11349435
• MDR Text Key: 232887623
• Report Number: MW5099505
• 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: 02/17/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/14/2022
• Device Model Number: E501RASR
• Device Catalogue Number: E501RASR
• Device Lot Number: 191114K
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1