MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION MODEL EAGLE II; VENTILATOR

Model Number	799-EGL2-00-01
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that during biomed testing, the device powered on without display.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The device was evaluated by zoll thailand.The customer's report was duplicated and attributed to front case kit w/button board.The front case kit w/button board needs to be replaced to resolve the report.The device was not recertified as the customer declined repair.Analysis for reports ofthis type has not identified an increase in trend.

• Brand Name: MODEL EAGLE II
• 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: 19881970
• Report Number: 1220908-2024-02766
• Device Sequence Number: 11770661
• Product Code: CBK
• UDI-Device Identifier: 00847946023447
• UDI-Public: (01)00847946023447
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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-EGL2-00-01
• 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: 07/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2020
• 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 Sex: Unknown