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

Model Number AED PRO

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem Insufficient Information (4580)

Event Date 03/19/2023

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown), the device gave a "no shock advised" prompt for a rhythm clinicians believed was shockable.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

Zoll medical corporation evaluated the device and the device performed to specification.The device was put through extensive testing including on/off current testing without duplicating the report.Review of the clinical data showed a single analysis that resulted in a "no shock advised" was observed.During that analysis there was a cpr bar data.It was determined from the clinical files that performed as it's intended, and an artifact from the cpr affected the results.The device worked as expected.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: AED PRO
• 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: 16854656
• MDR Text Key: 314398272
• Report Number: 1220908-2023-01504
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 04/11/2023

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: 04/26/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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