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

Model Number 8011050101

Device Problem Failure to Discharge (1169)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2020

Event Type  malfunction  

Event Description

During code blue in ccu, patient's chest was opened at the bedside.Pt found to be in vfib and doctor attempted internal defibrillation x2 (two times) with internal paddles and electrodes.Defibrillator did not discharge despite multiple attempts.Staff applied external pads and defibrillated without any issues.Defibrillation was delayed by a couple minutes while pads were exchanged.Code event completed without additional events.Biomedical engineering confirmed internal handle failure after only 3 discharges in 10 test firings at 30 joules.Manufacturer response for internal defibrillation handles, zoll autoclavable internal handles (per site reporter).Manufacturer provided us with information on in-between patient checks and quarterly electronic validation checks as well as procedures on performing output test prior to each patient use.Manufacturer also informed us of 100 sterilization cycle limits on both the handle and internal electrode spoons.

• Brand Name: ZOLL 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: 10884391
• MDR Text Key: 217663744
• Report Number: 10884391
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/19/2020,11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8011050101
• Device Catalogue Number: 8011050101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/19/2020
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA