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

Model Number	AED PLUS
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	01/17/2022
Type of Reportable Event	Death
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device displayed a "check pads" message.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The device was returned to zoll medical canada and there was no indication of a device malfunction.The device passed all testing using the returned pads and a known good set of pads without duplicating the report.The device was recertified and returned to the customer.Review of the device logs shows evidence of poor coupling.There are several padz off messages indicating that the patient impedance had gone out of range.The ecg waveform acquired has artifacts, baseline wandering, and signal railing.Electrode labeling states the importance of good placement on the patient and provides instruction for proper electrode application technique.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: AED PLUS
• Common Device Name: 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: 13456733
• Report Number: 1220908-2022-00417
• Device Sequence Number: 12296526
• Product Code: MKJ
• UDI-Device Identifier: 00847946024222
• UDI-Public: 00847946024222
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011541/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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
• Operator of Device: Other
• Device Model Number: AED PLUS
• Device Catalogue Number: AED PLUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown