MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION Z VENT; VENTILATOR

Model Number	799-AEB1-00-01
Medical Device Problem Codes	Mechanical Problem (1384); Unexpected Shutdown (4019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit shut off (no fault found) the device was returned to zoll medical corporation for evaluation.The report unit shut off could not be confirmed.Device logs showed three short usage periods on the event date with no alarms or abnormal operating conditions indicative of a malfunction.Review of temperature, battery status, state of charge, and input voltage revealed no abnormalities.The device does not record explicit power-off events; therefore, the exact reason for shutdown could not be determined.Functional testing, internal inspection, and battery evaluation were performed with no faults identified.The device met all performance specifications.#1001 self check failure alarm (observed in device data) device data confirmed a single #1001 self check failure alarm at startup associated with the pneumatic system (compressor condition).This alarm can be caused by turning the vent on with the dust cover over the port which is recoverable.The alarm did not recur, and no hardware malfunction was identified during evaluation.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device display a "compressor failure- 1001" and inappropriately shut down.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

• Brand Name: Z VENT
• 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: 24363253
• Report Number: 1220908-2026-00406
• Device Sequence Number: 9888631
• Product Code: CBK
• UDI-Device Identifier: 00847946024192
• UDI-Public: (01)00847946024192
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/27/2026

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: Health Professional
• Device Model Number: 799-AEB1-00-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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