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

Model Number R- SERIES ALS

Device Problems Thermal Decomposition of Device (1071); Failure to Discharge (1169)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2022

Event Type  Injury  

Event Description

Defibrillator failed to discharge without producing an error.Charring noted on paddles.Issue reproducible.During catheterization case at (b)(6), physician required to defibrillate patient.Charged unit, which signaled ready.When button pushed to discharge, no charge was delivered.Another defibrillator was procured from an adjacent room and patient was defibrillated back to normal without harm to patient.Unit and paddles were sequestered and sent to clinical engineering for review.Upon disassembly, charring noted on paddles (movie file available upon request).Device re-assembled and bench testing showed that intermittently charges would not discharge.No errors or alarms on device when charge is not going to be delivered.Vendor contacted.Device was provided to vendor for internal review.Bench testing within clinical engineering at the site was able to duplicate the issue.This is the second similar event, the first occurring in (b)(6) 2022.Vendor declined to investigate the (b)(6) 2021 incident.As there is no warning when these events occur, the hospital is concerned about patient safety as this is a critical piece of equipment.Issue seems to only occur when using paddles and not pads.Fda safety report id# (b)(4).

• Brand Name: DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; chelmsford MA 01825 4105
• MDR Report Key: 14218671
• MDR Text Key: 290271201
• Report Number: MW5109371
• Device Sequence Number: 2
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/22/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: R- SERIES ALS
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 115 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White