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

Model Number AED PLUS

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 01/12/2023

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 defibrillate a 42-year-old male patient, after an analysis determination and the device stating to "resume cpr", the clinician attempted to resume cpr compressions and upon pressing down for the first compression she felt a jolt or shock.The complainant indicated that there was no adverse effect to the patient and the clinician did not require medical treatment due to the reported malfunction.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device and it is also correcting information submitted on the initial medwatch report.Please reference section b3.Evaluation results: zoll medical corporation evaluated the device and the customer's report was not replicated or confirmed.The device was put through extensive testing including bench handling and electrical testing without duplicating the report.The device was recertified and returned to the customer.The clinical log review showed no instances of the device delivering a shock during the case.The log showed that an analysis was performed which returned a no shock advised determination.There is no evidence in the log file that the device charged or delivered energy.No evidence on the patient's ecg that any energy was delivered from another source.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: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 16480978
• MDR Text Key: 310640343
• Report Number: 1220908-2023-00740
• 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: 02/08/2023

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• 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): Other
• Patient Age: 42 YR
• Patient Sex: Male