MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION Z VENT; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	799-EMBP-05-01
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Insufficient Information (4580)
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 while attempting to monitoring a patient (age & gender unknown), the device displayed "internal comm failed -1173", "internal comm failed-1471" and "internal comm failed-1475" error messages.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Correction: d2.The device was returned to zoll medical corporation; the customer's reports were duplicated and attributed to a defective main battery.The battery was replaced to resolve the report.The device was 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, CONTINUOUS, FACILITY USE
• 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: 25201704
• Report Number: 1220908-2026-01753
• Device Sequence Number: 15961503
• Product Code: CBK
• UDI-Device Identifier: 00847946024185
• UDI-Public: (01)00847946024185
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/29/2026

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-EMBP-05-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2026
• 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: 04/29/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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