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

Model Number	31424785
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported the electrodes often come off and do not stay in place.They need to be replaced often.This problem causes bad capture of the heart and/or respiratory rhythm as well as false reading or alarm results.Anecdotally, the customer reported that this event occurred on numerous instances, but is unable to quantify an exact amount.

• 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: 8700156
• Report Number: 9681860-2019-00504
• Device Sequence Number: 11351538
• Product Code: DRX
• UDI-Device Identifier: 20884527005021
• UDI-Public: 20884527005021
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2019

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
• Device Lot Number: 901826X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 06/14/2019
• Patient Sequence Number: 1