MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION STAT PADS ELECTRODES

Model Number 8900-4003

Device Problem Arcing (2583)

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

Event Date 03/06/2014

Event Type  malfunction  

Event Description

Complainant alleged that while defibrillating a (b)(6), male pt, an arc was heard from the electrode pads.Complainant did not indicate an adverse effect to the pt due to the reported malfunction.

Manufacturer Narrative

Zoll medical corp has not received the device for eval and this complaint is still under investigation.

• Brand Name: STAT PADS ELECTRODES
• Type of Device: ELECTRODE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; chelmsford MA
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 3850312
• MDR Text Key: 16055742
• Report Number: 1220908-2014-00722
• Device Sequence Number: 1
• Product Code: MLN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2015
• Device Model Number: 8900-4003
• Device Catalogue Number: 8900-4003
• Device Lot Number: 4513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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
• Patient Age: 59 YR