MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION MODEL EAGLE II, MRI; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	799-EGL2-02-01
Medical Device Problem Code	Mechanical Problem (1384)
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.During the investigation it was noted that no event date was provided but a review of the device log on (b)(6) 2026 shows self-check faults triggered 3 times.Prior to the self-check faults several alarms were triggered multiple times.These alarms were observed throughout the device log history and are consistent with conditions associated with patient/circuit interaction issues, including leaks, kinked hoses, asynchronous breathing, defective or third-party patient circuits and/or incompatible patient settings.The ventilator successfully passed all stress and troubleshooting testing using a known-good test setup, with no inappropriate alarms observed.The flow screens were replaced as a precaution.The investigation is closed as observed in device data.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that during biomed testing, the device displayed a "compressor fault 2001 and 3001 " error messages.Complainant indicated that there was no patient involvement in the reported malfunction.

• Brand Name: MODEL EAGLE II, MRI
• 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: 25456775
• Report Number: 1220908-2026-02000
• Device Sequence Number: 10409899
• Product Code: CBK
• UDI-Device Identifier: 00847946023454
• UDI-Public: (01)00847946023454
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/21/2026

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-EGL2-02-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2017
• 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