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

Model Number	AED PLUS
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to treat a (b)(6) male patient, the device was unable to analyze.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.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.The customer's report was not replicated or confirmed.Review of the device log shows that electrodes were not detected by the device on what appears to be the event.The aed plus does not log exact date/times, so it cannot be determined if this is from the event.If no pads are detected by the device, a valid patient impedance will also not be detected.Without a valid patient impedance, the device will not perform an analysis or record a clinical file.The device passed all testing without duplicating the report.The pads used during the event were not returned.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
• MDR Report Key: 11957763
• Report Number: 1220908-2021-01783
• Device Sequence Number: 19768675
• Product Code: MKJ
• UDI-Device Identifier: 00847946002169
• UDI-Public: 00847946002169
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K011541/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

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
• Operator of Device: Other
• Device Model Number: AED PLUS
• Device Catalogue Number: AED PLUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR