MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION Z VENT; VENTILATOR

Model Number	799-EMBP-05-01
Medical Device Problem Codes	Communication or Transmission Problem (2896); Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device displayed \"5v self check failure - 1172\" and \"internal comm failure- 1474\" error messages.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Additional Manufacturer Narrative
Correction: d2.\ \ the device was returned to zoll medical corporation for evaluation.Per the customer's report, the ventilator was reportedly positioned approximately 12 feet from the mri bore opening during use, which exceeded the operator's guide recommendation for placement behind the 130-gauss field line.Device logs recorded alarms #1172 (self check failure) and #1474 (internal comm spm) during the reported timeframe.Alarm #1172 indicates the 5vcd power bus failed to provide the required voltage, while #1474 is triggered when cyclic redundancy communication checks between the device and smart pneumatic module (spm) fail.The device underwent stress testing, internal inspection and all functional testing with no faults or discrepancies identified.Emi interference associated with mri proximity could not be ruled out as a contributing factor.Replacement of the spm and power interface module (pim) boards was recommended 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.

• Brand Name: Z VENT
• 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: 25034863
• Report Number: 1220908-2026-01319
• Device Sequence Number: 21126054
• Product Code: CBK
• UDI-Device Identifier: 00847946024185
• UDI-Public: (01)00847946024185
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2026

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: Health Professional
• Device Model Number: 799-EMBP-05-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2019
• 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