MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION CPR STAT PADS; ELECTRODE

Model Number 8900-0400

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Complainant alleged that during functional testing, the associated device prompted a "unit failed" message when electrodes were attached.Complainant indicated that there was no patient involvement in the malfunction.

Manufacturer Narrative

Zoll medical corporation has not received the product and will be providing a follow-up report when our investigation is completed.

• Brand Name: CPR STAT PADS
• Type of Device: ELECTRODE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; chelmsford MA
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824-4105 ; 9784219552
• MDR Report Key: 3795804
• MDR Text Key: 4364783
• Report Number: 1220908-2014-00852
• Device Sequence Number: 1
• Product Code: MLN
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2015
• Device Model Number: 8900-0400
• Device Lot Number: 4413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1