MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AED PRO; DEFIBRILLATOR

Model Number AED PRO

Device Problem Incorrect Interpretation of Signal (1543)

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

Event Date 12/20/2022

Event Type  malfunction  

Event Description

Complainant alleged that while attempting to defibrillate a 54-year-old female patient, 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 received the product and will be providing a supplemental report when our investigation is completed.

Manufacturer Narrative

Zoll medical corporation evaluated the device and the device successfully passed all testing.Review of the clinical files showed there was two analyses that were performed during the event, and shock was advised on one of the analysis.Zoll defibrillators function by taking a nine second ecg sample and dividing it into three, 3 seconds segments.Algorithm will make calculations based on ten waveform characteristics for each segment.For shock to advised a minimum of two of the three segments need to be identified as shockable.Review of the clinical files determined the aed pro device was functioning as it's designed and configured, within the limitations of the technology available.This investigation has been closed as device meets specification.No trend is associated with reports of this type.

• Brand Name: AED PRO
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 16241888
• MDR Text Key: 308109198
• Report Number: 1220908-2023-00134
• Device Sequence Number: 1
• Product Code: MKJ
• 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,Followup
• Report Date: 01/04/2023

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: AED PRO
• Device Catalogue Number: AED PRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 01/25/2023
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2007
• 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 Age: 54 YR
• Patient Sex: Female