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

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problems Cardiac Arrest (1762); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 06/17/2020

Event Type  malfunction  

Event Description

Female patient experienced cardiac arrest while in a cardiac stepdown unit.A zoll aed plus was used to shock the heart.Return of spontaneous circulation was obtained.The patient was transferred to the coronary care unit.In the coronary care unit the patient went into ventricular tachycardia and ventricular fibrillation.This time the zoll aed plus would not shock the heart.The staff checked all the wires and vermed heartsync pads connections, but the zoll aed plus would not deliver a shock.The staff changed the vermed heartsync pads, however the zoll aed plus still would not shock.The staff substituted the zoll aed plus with another zoll aed plus and shocked patient.The zoll aed plus that failed had passed the quality checks done at the beginning of the shift.The zoll aed plus that failed to shock was taken out of service and biomed notified to come and pick it up for service.No untoward patient effects.

• Brand Name: ZOLL AED PLUS
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 10188472
• MDR Text Key: 196230149
• Report Number: 10188472
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22265 DA