MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION MAIN ASSEMBLY, VENTILATOR, COMMERCIAL, ZVENT, BASI

Model Number	799-AEB1-00-01
Medical Device Problem Codes	No Display/Image (1183); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device was unable to deliver breaths and the device's display blanked out.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Justification for no udi: this device has a udi; some information was not provided and is unknown; therefore, a complete udi cannot be provided.Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
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 d4 serial # and d4 primary udi # updated.The device was returned to zoll medical corporation for evaluation.The customer's report was confirmed to be caused by a defective central processing unit (cpu) board.The cpu board was replaced to remedy the report.The device was recertified and returned to the customer.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: MAIN ASSEMBLY, VENTILATOR, COMMERCIAL, ZVENT, BASI
• 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: 22512464
• Report Number: 1220908-2025-02528
• Device Sequence Number: 18453262
• Product Code: CBK
• UDI-Device Identifier: 00847946094546
• UDI-Public: (01)00847946094546
• 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): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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-AEB1-00-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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