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

Model Number	799-EMVP-05-01
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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 during functional testing, the device displayed "internal comm failure 1474" message.Complainant did not indicate that there was any patient involvement in 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 sections a1, a4, 5b, 6b, 7b, h6 (health effect clinical code) and h6 (health effect impact code) updated.The device was returned to zoll medical corporation for evaluation.Alarm 1474 is a self-check failure caused by a communication issue between the device and the smart pneumatic module (spm), which triggers a high priority alarm while ventilation continues at the set or backup mode.The communication ribbon cable was found loose at the connector and may have contributed to the customer report.The cable will be replaced as a precaution.The device will be recertified and returned to the customer.Analysis for reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age and gender unknown), the device displayed "internal comm failure 1474" message.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

• Brand Name: MODEL EMV+, COMM, 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: 22457721
• Report Number: 1220908-2025-02278
• Device Sequence Number: 12910858
• Product Code: CBK
• UDI-Device Identifier: 00847946023430
• UDI-Public: (01)00847946023430
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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-05-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2019
• 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