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

Model Number M-SERIES

Device Problem Failure to Read Input Signal (1581)

Patient Problems Cardiac Arrest (1762); Ventricular Fibrillation (2130)

Event Date 08/16/2019

Event Type  malfunction  

Event Description

Patient went into vfib arrest.The zoll on the cart would charge to the intended 200 j but was unable to shock."ppr pad connect" displayed.Pads in place and plugged in properly.Equipment removed rom service and tagged for repair.Defib test ok after malfunction.Replacement zoll quickly pulled and used on patient.

• Brand Name: M SERIES
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 16814601
• MDR Text Key: 314012983
• Report Number: 16814601
• Device Sequence Number: 1
• Product Code: MKJ
• 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: 04/19/2023,08/20/2019

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 Model Number: M-SERIES
• 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: 04/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17520 DA
• Patient Sex: Male