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

Model Number AED PLUS

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem Insufficient Information (4580)

Event Date 11/23/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Complainant alleged that while attempting to treat a 69-year-old patient (gender unknown), the device issued a "shock advised" prompt for a heart rhythm they believe was non-shockable.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

The device was not returned to zoll medical corporation for evaluation.Instead, the data file of the customer's report was provided.Review of the data file indicated cpr was being performed during the analysis and contributed to the shock advised result.The manual states to "keep patient motionless during ecg analysis.Do not touch the patient during analysis.Cease all movement via stretcher or vehicle before analyzing the ecg".Based on our review of the data, we have concluded that the analysis program results were correct for the specific analyses in question.No trend is associated with reports of this type.

• Brand Name: AED PLUS
• 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: 18463180
• MDR Text Key: 332266358
• Report Number: 1220908-2023-05104
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011541/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

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: Other
• Device Model Number: AED PLUS
• Device Catalogue Number: AED PLUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 YR