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

Model Number	799-EMBP-05-01
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device displayed a "compressor fault-3001 " and "compressor fault-2001 " messages.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation.During the investigation it was noted that the customer reported the event date was 11 december 2025; however, the events described match entries on 10 december 2025.A log review was performed evaluating events on 10 december 2025.The customer report could not be duplicated under stress testing.The device passed all calibration testing.The device was internally inspected and no discrepancies were found with the cables and tubing.The flow screens for both the compressor and o2 supply were observed to have some dust or debris in them.Dust or debris in the flow screens can cause flow restrictions (increased resistance) and produce user advisories.The flow screens were replaced as a precaution.The device was recertified and returned to the customer.No emerging trend based on similar reports.

• 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: 23908803
• Report Number: 1220908-2025-04813
• Device Sequence Number: 15975072
• Product Code: CBK
• UDI-Device Identifier: 00847946024185
• UDI-Public: (01)00847946024185
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/11/2025

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-EMBP-05-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2025
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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