MAUDE Adverse Event Report: ZOLL Medical Corporation BELLAVISTA; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	301.100.030
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Customer stated the device was having fio2 mismatch issues while in use on patient.There was no patient harm reported.
Additional Manufacturer Narrative
The device was not returned to zoll medical corporation.During the investigation it was noted that a review of the device logs confirmed the condition and indicated that the inspiration block required replacement.A technician was dispatched to the customers site to evaluate the unit.The inspiration block was replaced, resolving the issue.

• Brand Name: BELLAVISTA
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): ZOLL Medical Corporation; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: anne nadeau ; plo 1 jalan firma 1 kawasan; perindustrian tebrau 1; johor bahru ; +1(351)500-4978
• MDR Report Key: 24420596
• Report Number: 3013421741-2026-00071
• Device Sequence Number: 10608213
• Product Code: CBK
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2026

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: 301.100.030
• Device Catalogue Number: 301.100.030
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 04/01/2026; 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2022
• 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