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

Model Number AED PLUS

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem Necrosis (1971)

Event Date 04/29/2023

Event Type  Death  

Event Description

Complainant alleged that while attempting to treat a female patient in her late 50s, 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

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 performed to specification.The device passed the final test and was recertified and returned to the customer.The ecg analysis of the recorded clinical file was reviewed.There were twelve analyses performed during the event, for one of which a shock was advised.The report reviewed the "shock advised".The first analysis in the case resulted in a shock advised.Of the three segments of the ecg analysis, segments 1 and 2 were determined to be shockable, presenting vtach greater than 150 bpm.The main contributing factors to this result were high recorded heart rates, low normalized amplitudes, high qrs variabilities, and high recorded percent width measurements in each segment.The remaining eleven analysis events all resulted in non-shockable determinations, and all contained clear asystolic rhythms and were correctly analyzed by the algorithm.It was determined that the aed plus device worked as designed and configured, and within the limitations of the technology available.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
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 16994660
• MDR Text Key: 315866233
• Report Number: 1220908-2023-01883
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946002237
• UDI-Public: 00847946002237
• 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: 05/03/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• 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 Outcome(s): Death
• Patient Sex: Female