MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AED3; DEFIBRILLATOR

Model Number AED3

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2023

Event Type  malfunction  

Event Description

Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device issued a "shock advised" prompt for a heart rhythm they believe was non-shockable.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.

Manufacturer Narrative

The device was not returned for evaluation.The clinical event data from the event was returned and evaluated.Review of the data file determined the shock advised prompt was a false positive due to a complex at the start of the segment that skewed the averages measured with the segment and resulted in the measurements erroneously matching definitions for ventricular fibrillation.Based on our review of the data we have concluded that the analysis program results worked within the limitation of the available technology.No trend is associated with reports of this type.

• 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: 17929374
• MDR Text Key: 325573845
• Report Number: 1220908-2023-03995
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

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: Other
• Device Model Number: AED3
• Device Catalogue Number: AED3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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