MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION MODEL EMV+ VENT, ARMY, COMMERCIAL; VENTILATOR

Model Number	799-EMVP-01-01
Medical Device Problem Codes	Mechanical Problem (1384); Use of Device Problem (1670); Contamination /Decontamination Problem (2895); No Flow (2991)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age and gender unknown), the device stopped ventilating and displayed an unknown compressor failure message.Complainant alleged they observed foreign contamination while treating the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age and gender unknown), the device displayed a "compressor fault-2001 " error message.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
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 b5 and h6 (medical device problem code).The device was returned to zoll medical corporation for evaluation.The customer's report of self-check fault 2001 alarm and concern about metal shavings being ejected from the device was unconfirmed during evaluation.The 2001 alarm was noted in the device logs; however, it could not be reproduced during testing, and no metal or foreign material was observed.The device passed all functional, stress, and calibration testing with a known good test setup.Inspection identified a small amount of non-metalic dust within the flow screens, which were replaced as a precaution.A fault 2001 alarm can occur due to temporary communication interruptions, setup conditions, or external factors and is not necessarily indicative of device malfunction.The exact cause of the reported event could not be determined.The device met all performance specifications following evaluation.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: MODEL EMV+ VENT, ARMY, COMMERCIAL
• 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: 23794932
• Report Number: 1220908-2025-04795
• Device Sequence Number: 5522226
• Product Code: CBK
• UDI-Device Identifier: 00847946023416
• UDI-Public: (01)00847946023416
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/30/2025

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-EMVP-01-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2025
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2019
• 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