MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL R SERIES DEFIBRILLATORS ALS ; AUTOMATED EXTERNAL DEFIBRILLATORS

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problems Death (1802); Loss Of Pulse (2562)

Event Date 03/10/2020

Event Type  malfunction  

Event Description

Zoll was charged and shock button was pressed, however no visible shock delivered to pt.Pads changed and attempted to shock pt again, again no noticeable shock delivered to pt.New zoll was noticeable shock delivered to pt.Pt arrived in asystole, post car accident into a river, found approx 30 mins later in cardiac, drowning listed as cause of death.Fda safety report id# (b)(4).

• Brand Name: ZOLL R SERIES DEFIBRILLATORS ALS
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 9834691
• MDR Text Key: 183875563
• Report Number: MW5093747
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2020

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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR