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

Model Number 31424785

Device Problem Device Sensing Problem (2917)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 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
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): COVIDIEN; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• Manufacturer (Section G): COVIDIEN; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5084524970
• MDR Report Key: 8700156
• MDR Text Key: 149797093
• Report Number: 9681860-2019-00504
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 20884527005021
• UDI-Public: 20884527005021
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 31424785
• Device Catalogue Number: 31424785
• Device Lot Number: 901826X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1