MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ONESTEP ECG LEADS; MONITOR, CARDIAC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Discoloration (2074)

Event Date 10/10/2019

Event Type  malfunction  

Event Description

Patient's skin was reddened at defibrillator pad sites after procedure.

• Brand Name: ONESTEP ECG LEADS
• Type of Device: MONITOR, CARDIAC
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 9853276
• MDR Text Key: 184079632
• Report Number: 9853276
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/04/2020

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19345 DA