MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION MODEL AEV (TAN, COMMERCIAL); VENTILATOR

Model Number	799-AEV1-00-01
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Insufficient Information (4580)
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 patient (age & gender unknown) the device inappropriately powered off.Complainant indicated that there were no adverse effects to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the customer's report was not replicated or confirmed.A "preventative maintenance (pm) due" alarm was present upon startup and in the logs, with pm due on (b)(6) 2024.Between 09/26/2024 and 10/29/2024, no critical, display, or communication errors were found.Power up events were logged, but no settings were recorded until (b)(6), suggesting the device was turned on but not used past the pm alarm screen.Power and environmental parameters were within normal range.Stress testing and internal inspection revealded no faults.All connections were secure, and battery diagnostics passed.The device passed calibration tests.Pm was completed, and the pim board was replaced as a precaution.No malfunction was confirmed; the device operated within specification throughout evaluation.The device was recertified and returned to the customer.No trend is associated with reports of this type.

• Brand Name: MODEL AEV (TAN, COMMERCIAL)
• Common Device Name: VENTILATOR
• 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: 21663350
• Report Number: 1220908-2025-00899
• Device Sequence Number: 7662054
• Product Code: CBK
• UDI-Device Identifier: 00847946023461
• UDI-Public: (01)00847946023461
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K162832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2025

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: 799-AEV1-00-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2025
• 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: 02/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2018
• 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