MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION 731 VENTILATOR

Model Number	799-EMVP-01-01-66
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
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 55-year-old male patient, in cpap and simv modes, the device displayed an "airway pressure sensing failure - 1052 error message." complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The device was evaluated by a field service technician onsite with no discrepancies noted.Event logs were not available for review, but the customer provided a photo of the 1052 error on a device.The service code indicates a communication problem between the airway pressure sensor and the smart pneumatic module (spm) pcba.The device passed all onsite testing with no issues notes.Unable to determine if the patient coughing repeatedly was a factor as communicated by the clinician.The device was recertified onsite and returned to clinical use.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: 731 VENTILATOR
• 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: 22175810
• Report Number: 1220908-2025-02054
• Device Sequence Number: 7957774
• Product Code: CBK
• UDI-Device Identifier: 00812394023462
• UDI-Public: (01)00812394023462
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/20/2025

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-01-01-66
• Was Device Available for Evaluation?: No
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• 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 Age: 55 YR
• Patient Sex: Male