MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AED3; DEFIBRILLATOR

Model Number AED3

Device Problem Unintended Electrical Shock (4018)

Patient Problem Cardiac Arrest (1762)

Event Date 09/01/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned to zoll medical corporation for evaluation.The customer's report was observed and attributed to incorrect use of device during review of the clinical data log.The use of aed on a patient that is not in a cardiac arrest and or conscious is not indicated the product indications for use.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

Event Description

Complainant alleged that while attempting to defibrillate a 46-year-old male patient, the device inadvertently delivered a 120 joule shock to a conscious patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

• Brand Name: AED3
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 17846782
• MDR Text Key: 324627614
• Report Number: 1220908-2023-03790
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946020064
• UDI-Public: 00847946020064
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AED3
• Device Catalogue Number: AED3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Male