MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION VENT; VENTILATOR

Model Number	8660-001401-01
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.The customer reported that the ventilator would not operate in bipap mode.Log review identified 01/11/2026 as the event date, during which medium priority alarms for patient disconnection, apnea, and inspiratory demand were observed, along with transient low and subsequent high o2 supply alarms (up to 87 psi).The alarm activity suggests possible patient-ventilator asynchrony and/or suboptimal settings.Device evaluation, including stress testing, compressor, o2 flow, o2 kickstart calibration and internal inspection, found no faults.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
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 treat a patient (age & gender unknown), the device stopped ventilating.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.

• Brand Name: 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: 24511991
• Report Number: 1220908-2026-00644
• Device Sequence Number: 16062450
• Product Code: CBK
• UDI-Device Identifier: 00847946094645
• UDI-Public: (01)00847946094645
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P160022
• 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): 02/12/2026

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: 8660-001401-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2026
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2025
• 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