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

Model Number AED PLUS

Device Problem Self-Activation or Keying (1557)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2020

Event Type  malfunction  

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 (b)(6)-year-old male patient in cardiac arrest, the device self discharged.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The device was returned to zoll medical corporation and the device performed to specification.Review of the device logs indicated that the device appropriately advised a shock and advised to stand clear via audible prompts.This device is a fully automatic and does not have a manual shock button.It is designed to countdown and shock automatically when a shock is advised.Instructions for use specifically state the device is intended to be used by personnel who have been trained in the operation.The customer did disclose to zoll that the officer was not aware this was an automatic device.The device was put through extensive testing including full functionality testing without duplicating a malfunction.The device was recertified and returned to the customer.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: 10567148
• MDR Text Key: 207932487
• Report Number: 1220908-2020-02939
• 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: 09/01/2020

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: 09/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 09/01/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR