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

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 09/28/2020

Event Type  malfunction  

Event Description

Turned on zoll before cardioversion and the machine charged and delivered shock to patient before we were ready.

• Brand Name: ZOLL
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 10711269
• MDR Text Key: 212311208
• Report Number: 10711269
• 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: 10/01/2020

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1