MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED PADDLES; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Model Number 8011-0139-04

Device Problem Defective Component (2292)

Patient Problem Ventricular Fibrillation (2130)

Event Date 12/29/2018

Event Type  Injury  

Event Description

The patient was undergoing cardiac surgery.While coming off bypass the patient went into ventricular fibrillation (v-fib).The internal defibrillator paddles did not work.The activation button on the hand-piece did not work and could not be depressed.There was no clicking of the spring-loaded mechanism under the silicone or rubber(?) activation button on the hand piece.The operating room team was required to get a second set of defibrillator paddles which took approximately two extra minutes.This same event has happened with two other patients in the last month and in all cases the activation button on the hand-pieces was defective.We have found five defective sets and will be providing some to zoll for testing.We are reviewing our inventory for additional defective hand-pieces.Manufacturer response for autoclavable internal handles with integrated paddles, zoll (per site reporter).They will test sets that we provide.

• Brand Name: AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED PADDLES
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill rd.; chlemsford MA 01824 4105
• MDR Report Key: 8260130
• MDR Text Key: 133482447
• Report Number: 8260130
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8011-0139-04
• Device Catalogue Number: 8011-0139-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2019
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 16790 DA
• Patient Weight: 94