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

Model Number AED PLUS

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem No Information (3190)

Event Date 12/02/2020

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 defibrillate a 59-year-old female patient, the device issued a "shock advised" prompt for a heart rhythm they believe was non-shockable.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The device was returned to zoll medical corporation.Review of the clinical data file shows that the waveform analyzed had a very low voltage amplitude which contributed to the algorithm accuracy.This is common for a patient with pulseless electrical activity.The first segment was too noisy, and therefore not shockable.The second and third segments had low normalized amplitude and high qrs variability which was shockable.It is determined that the device delivered an incorrect result for this analysis due to limitations of the technology available.The customer declined recertification testing of the 10 year old device and was returned as requested.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: AED PLUS
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 11058114
• MDR Text Key: 223356579
• Report Number: 1220908-2020-04257
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K011541/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

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 PLUS
• Device Catalogue Number: AED PLUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 12/04/2020
• Supplement Dates FDA Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR