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

Model Number	799-EMVP-01-01
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device stopped ventilating.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The device is returned to zoll medical corporation for evaluation.Device log review confirmed the ventilator operated in bipap pressure target mode with no ventilation stoppage or critical device alarms.Patient related alarms (patient disconnect, apnea, peep leak, ispiratory demand) and breath log data indicating lower pressures and elevated tidal volumes suggest a circuit leak, poor patient interface, or patient-ventilator asynchrony.The reported humming noise was consistent with the compressor compesating to reach the pressure target.Low o2 supply fault alarms occurred when the device was switched to 100% o2 suggesting supply may have been a factor.The customer report could not be duplicated during testing; the device passed calibration testing and internal inspection found no discrepancies.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: 24268562
• Report Number: 1220908-2026-00384
• Device Sequence Number: 10722968
• Product Code: CBK
• UDI-Device Identifier: 00847946023416
• UDI-Public: (01)00847946023416
• 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): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2026

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: 799-EMVP-01-01
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2015
• 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