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

Model Number	799-EMVP-04-01
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.The reported issue could not be duplicated.Event log review identified alarms #2020 (low o2 supply fault) and #2100 (patient disconnect).These alarms are not necessarily indicative of device malfunction and may result from improper patient circuit setup, ventilator settings, patient effort during inspiration, low or depleted oxygen supply, regulator issues, circuit leaks, or loose mask fit.Stress testing and internal inspection, including tubing evaluation, found no faults or discrepancies.The device passed all functional tests.No device malfunction was confirmed.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
Additional Manufacturer Narrative
The customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device displayed an unrecognized "short in system" error message.Complainant indicated that the clinician obtained another set of pads to continue treating the patient.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 not received the device for evaluation and this complaint is still under investigation.

• Brand Name: MODEL EMV+ VENT, ARMY, MRI
• 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: 23729849
• Report Number: 1220908-2025-04566
• Device Sequence Number: 18579566
• Product Code: CBK
• UDI-Device Identifier: 00847946023423
• UDI-Public: (01)00847946023423
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 11/18/2025

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-04-01
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/26/2026; 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2020
• 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