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

Model Number 8900-0400

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 05/10/2023

Event Type  malfunction  

Event Description

Ems zoll defibrillation pads faulted while performing cpr on a patient in the field.Had to replace with new pads.Reference report: mw5118007.

• Brand Name: ZOLL DEFIB PADS
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; chelmsford MA
• MDR Report Key: 17038952
• MDR Text Key: 316400595
• Report Number: MW5118008
• Device Sequence Number: 1
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/26/2023

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 Expiration Date: 03/26/2024
• Device Model Number: 8900-0400
• Device Lot Number: 1322D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Male