MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL PADDLES; ZOLL PADDLES DC - DEFIBRILLATOR, LOW ENERGY

Model Number R SERIES

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problems Ventricular Fibrillation (2130); Shock from Patient Lead(s) (3162)

Event Date 05/14/2019

Event Type  Injury  

Event Description

During the pt's heart cath, the pt went into v-fib; attempted to shock the pt with zoll paddles at 200 j x 2 attempts (with monitor buttons and then the paddle buttons) with no success.Cpr continued and another defibrillator had to be used to shock the pt.The pt was successfully shocked and returned to nsr.Fda safety report id# (b)(4).

• Brand Name: ZOLL PADDLES
• Type of Device: ZOLL PADDLES DC - DEFIBRILLATOR, LOW ENERGY
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 8636161
• MDR Text Key: 146066135
• Report Number: MW5086841
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/21/2019

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: Health Professional
• Device Model Number: R SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2019
• 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): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 95