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

Catalog Number 8011-0501-01

Device Problems Defibrillation/Stimulation Problem (1573); Output Problem (3005)

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

Event Date 07/23/2018

Event Type  malfunction  

Event Description

After cardio pulmonary bypass defibrillation was needed using internal paddles set at 5 joules.There was a delay between pushing the button and delivering joules.The first time nothing was delivered.The button was pushed three more times at 5 joules and only 1 joule was actually delivered.Was in the process of switching to another set of defibrillator handles when the patient converted.Reported issue was investigated, it was determined that the internal paddles were 17 years old and passed its sterilization cycle threshold of 100 sterilizations.Manufacturer response for defibrillator paddles, zoll (per site reporter).Paddles were beyond recommended age.Zoll provided ordering information for new paddles.

• Brand Name: AUTOCLAVABLE INTERNAL HANDLES
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 8173754
• MDR Text Key: 130648713
• Report Number: 8173754
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8011-0501-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2018
• Device Age: 17 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 365 DA