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

Model Number	799-AEV1-00-01
Medical Device Problem Codes	Improper Flow or Infusion (2954); Reset Problem (3019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/08/2024
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 stopped ventilating.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device stopped ventilating and restart/reboot itself.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section b5 and h6 (medical device problem code).Evaluation results: the device was returned to zoll medical corporation.The customer's report of the device restart/reboot itself was observed during initial testing; however, after disassembling the device to determine root cause, the report was no longer seen.The device was put through extensive testing including stress testing without duplicating the report.The power input assembly and main battery were replaced to remedy the report.The customer's report of the device stopped venting was not replicated or confirmed.The device passed all testing without producing a malfunction to the device.The device passed was recertified and returned to the customer.Analysis for reports of this type has not identified an increase in trend.

• 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: 20556193
• Report Number: 1220908-2024-03869
• Device Sequence Number: 19646024
• Product Code: CBK
• UDI-Device Identifier: 00847946023461
• UDI-Public: (01)00847946023461
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 10/08/2024

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: 799-AEV1-00-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2024
• 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: 10/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2017
• 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