MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PRO-PADZ; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number 8900-4006

Device Problems Sparking (2595); Noise, Audible (3273)

Patient Problem Burn, Thermal (2530)

Event Date 08/28/2019

Event Type  Injury  

Event Description

During cardioversion shock, a popping sound and visible spark was seen on the chest pad.The pt had two semicircular burns found underneath the chest pad, no burns underneath the back pad.The cardioversion was successful.Fda safety report id# (b)(4).

• Brand Name: PRO-PADZ
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION ; chelmsford MA 01824
• MDR Report Key: 9134730
• MDR Text Key: 160677238
• Report Number: MW5090097
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2020
• Device Catalogue Number: 8900-4006
• Device Lot Number: 2019A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 93