MAUDE Adverse Event Report: COVIDIEN ELECTRODE LARGE PUPPYDOG PEDIATRIC; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	31424785
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported that they were using neomed pre-wired leads (sin #(b)(4)) and were asked to convert to sin # (b)(4) (cardinal health item code 31424785) for contract compliance and savings.Sin # (b)(4) is used outside of the nicu without issue.The nicu has been using sin # (b)(4) since (b)(6) 2020.The nicu manager is reporting several complaints similar to the following from a nicu charge rn: the new electrodes are very frustrating to work with.They do not stay on and when they are on, they are usually reading arrhythmia.They are using so many more because of these issues that they doubt any projected savings will be realized.They are afraid that they are contributing to the alarm fatigue that could cause safety issues in the unit as well.They have heard nothing but complaints over the weekend.The nicu has converted back to the previous neomed product sin # (b)(4).Additional information provided by the customer stated that each time the electrodes have read arrhythmia, the signal has been false/inaccurate.It is not known exactly how many patients this issue has occurred with but on any given day they had at least 2-3 patients with alarming issues and had to verify and replace the leads while using the product.The event dates are not known but the issues occurred from the time they started using these electrodes until the time they switched back to the previous product.There has been no patient harm associated with the false arrhythmia signals and no unnecessary medical intervention was provided to any of the patient's involved.The readings of the false signals are not available to be shared.Several infants did have irritation to the skin due to multiple leads falling off in addition to replacing the leads that would alarm for arrhythmia.There was no medical intervention provided for the skin irritations.

• Brand Name: ELECTRODE LARGE PUPPYDOG PEDIATRIC
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): COVIDIEN; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• MDR Report Key: 11372622
• Report Number: 9681860-2021-00517
• Device Sequence Number: 3630817
• Product Code: DRX
• UDI-Device Identifier: 20884527005021
• UDI-Public: 20884527005021
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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
• Operator of Device: No Information
• Device Model Number: 31424785
• Device Catalogue Number: 31424785
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 02/24/2021
• Patient Sequence Number: 1