MAUDE Adverse Event Report: CONMED CORPORATION HUGGABLES; ELECTRODE, ELECTROCARDIOGRAPH

Catalog Number 1620-003

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 12/27/2017

Event Type  malfunction  

Event Description

Neonatal/pediatric ecg electrode huggables would not adhere to patient.Tried several different packages on several different patients.Ref # 1620-003 conmed corporation.

• Brand Name: HUGGABLES
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd; utica NY 13502 5994
• MDR Report Key: 7202979
• MDR Text Key: 97656052
• Report Number: 7202979
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/08/2019
• Device Catalogue Number: 1620-003
• Device Lot Number: 201702081
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES