MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION Z VENT; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	799-EGB2-00-01
Medical Device Problem Code	Tidal Volume Fluctuations (1634)
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 while attempting to treat a patient (age & gender unknown), the device displayed a " tidal volume high - 2072" error message.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 d2.The device was returned to zoll medical corporation for evaluation.It was reported that the ventilator delivered tidal volumes in excess of 3000ml.Device log review identified a relevant case on (b)(6) 2026 during which multiple high tidal volume events were recorded.Investigation of the device data determined that the elevated tidal volume measurements were associated with patient/circuit related conditions, including potential leaks, circuit issues, asynchronous breathing, improper masks fit, or incompatible patient settings.Functional testing and troubleshooting performed with a known good test setup did not reproduce the reported condition, no inappropriate high tidal volume area alarms were observed and internal inspection found no device abnormalities the device passed all functional testing and met specifications.Based on the available evidence the reported condition was attributed to factors observed in the device data.The device was certified for clinical use.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: Z VENT
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• 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: 25230727
• Report Number: 1220908-2026-01688
• Device Sequence Number: 17427022
• Product Code: CBK
• UDI-Device Identifier: 00847946024208
• UDI-Public: (01)00847946024208
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P160033
• 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): 05/01/2026

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-EGB2-00-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2026
• 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: 05/01/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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