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 04/02/2023

Event Type  Death  

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 defibrillate a 76-year-old female patient, the device gave a "no shock advised" prompt for a rhythm clinicians believed was shockable.Complainant indicated that the patient subsequently expired.

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 data indicated the criteria was not met for an advised shock due to chest compressions (cpr) being performed and contributing to no shock advised.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 and that there was no indication of a malfunction with the device.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: 16873106
• MDR Text Key: 314611958
• Report Number: 1220908-2023-01554
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946002152
• UDI-Public: 00847946002152
• 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: 04/13/2023

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: 04/19/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/04/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• 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 Age: 76 YR
• Patient Sex: Female