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

Model Number AED PLUS

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problems No Consequences Or Impact To Patient (2199); Brain Injury (2219)

Event Date 08/13/2020

Event Type  Injury  

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 patient (age & gender unknown), the device gave a "no shock advised" prompt for a rhythm clinicians believed was shockable.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Evaluation results: zoll medical corporation evaluated the device and the device performed to specification.The device was recertified and returned to the customer.Review of the clinical data showed that the first analysis (segments one and two) were impacted by interference caused by cpr being performed during the analysis period.It is imperative that cpr not be continued during the analysis period to avoid any interference occurring and impacting the waveform analysis.The device prompts users to "not touch patient" when analyzing.In addition to motion artifact, the complainant specified that the patient was a child, however the data showed that adult electrode pads were connected and being used.The device prompts "adult pads" when they are recognized by the device.The algorithm automatically adjusts its parameters depending upon the type of electrode pads used, so using the incorrect pads could also impact the results of the analysis.Per the 9650-0310-01 sf administrators guide, the device must be used by personnel trained in its operation and "when a victim is less than 8 years old of age or weighs less than 55 lbs.(25 kg), the zoll aed plus should be used with pediatric electrodes." based on our review of the data we have concluded that the analysis program results were correct for the specific analysis 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.

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 this event led to brain damage to the patient.

• Brand Name: AED PLUS
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 10488295
• MDR Text Key: 205499428
• Report Number: 1220908-2020-02755
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946002237
• UDI-Public: 00847946002237
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• 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: 10/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability