MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL ECG ELECTRODES; ELECTRODE, ELECTROCARDIOGRAPH

Model Number 8900-0005

Device Problems Defective Component (2292); Detachment of Device or Device Component (2907)

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

Event Date 11/18/2019

Event Type  malfunction  

Event Description

Metal grommet pops off too easy.Defective product.

• Brand Name: ZOLL ECG ELECTRODES
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 9391743
• MDR Text Key: 168447392
• Report Number: 9391743
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8900-0005
• Device Catalogue Number: 8900-0005
• Device Lot Number: 199458
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/22/2019
• Event Location: Other
• Date Report to Manufacturer: 11/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1