MAUDE Adverse Event Report: LEAD-LOK, INC. ACCUSENSOR DIAGNOSTIC ECG ELECTRODES; ELECTRODE, ELECTROCARDIOGRAPH

Catalog Number ST-50

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/21/2015

Event Type  malfunction  

Event Description

These patches left a brown residue on the patient's chest.The nurse looked down at these patches and they were rusted over.There were a couple more in the package that looked the same (rusty).Packaging was intact.The electrodes are stored in a temperature and humidity controlled environment.

• Brand Name: ACCUSENSOR DIAGNOSTIC ECG ELECTRODES
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): LEAD-LOK, INC.; 814 airport way; sandpoint ID 83864
• MDR Report Key: 4948997
• MDR Text Key: 20123679
• Report Number: 4948997
• Device Sequence Number: 1
• Product Code: DRX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: ST-50
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1