MAUDE Adverse Event Report: MEDLINE ECG ELECTRODES NEONATAL 1.5MM; ELECTRODE, ELECTROCARDIOGRAPH

Device Problems Break (1069); Disconnection (1171)

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

Event Date 04/11/2016

Event Type  malfunction  

Event Description

The patient was on a cardiac monitor, but the electrodes broke and wires became disconnected from the 'gel sticker' on chest.

• Brand Name: ECG ELECTRODES NEONATAL 1.5MM
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): MEDLINE; one medline place; mundelein IL 60060
• MDR Report Key: 5670951
• MDR Text Key: 45656930
• Report Number: 5670951
• 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: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2016
• 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