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

Model Number	AED PLUS
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 during functional testing, the device prompted a "unit failed" message.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation; the customer's report was duplicated and the main board was replaced to resolve the report.The board was scrapped after testing.The customer was sent a replacement device.Analysis for 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: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 18921120
• Report Number: 1220908-2024-00930
• Device Sequence Number: 7683172
• Product Code: MKJ
• UDI-Device Identifier: 04560233596016
• UDI-Public: 04560233596016
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

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: 03/14/2024
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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
• Patient Sex: Unknown