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

Model Number	799-AEB1-00-01
Medical Device Problem Codes	Improper Flow or Infusion (2954); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unkown), the device stopped ventilating and displayed an unrecognized "short in system" error message.The patient rapidly desaturate to 89%.Power cycling restored airflow, and bipap resumed at 100% fio2 without further issue.
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

• 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 ; +1(978)421-9552
• MDR Report Key: 50913688
• Report Number: 1220908-2026-03960
• Device Sequence Number: 17491233
• Product Code: CBK
• UDI-Device Identifier: 00847946024192
• UDI-Public: (01)00847946024192
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): N
• Reporter Type: Manufacturer
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 799-AEB1-00-01
• Was Device Available for Evaluation?: No
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown