MAUDE Adverse Event Report: EVENT MEDICAL LTD. INSPIRATION 7I; INSPIRATION VENTILATOR SYSTEM

Model Number	INSPIRATION 7I
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to event medical: it was reported that while in use on a patient, the screen of the ventilator went black.The equipment was ventilating and working all the time, without stopping ventilation,the patient was placed on an alternate ventilator with no injury reported.The third party service personnel replaced the device's display which corrected the issue.
Additional Manufacturer Narrative
Patient information was requested but not provided.The third party service personnel confirmed the reported issue.Sp replaced the device's display to address the issue.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all event medical quality specifications.The manufacturer's investigation is ongoing.

• Brand Name: INSPIRATION 7I
• Common Device Name: INSPIRATION VENTILATOR SYSTEM
• Manufacturer (Section D): EVENT MEDICAL LTD.; 60 empire drive; lake forest CA 92630
• Manufacturer (Section G): EVENT MEDICAL LTD.; 60 empire drive; lake forest 92630
• Manufacturer Contact: azita hedayati ; 60 empire drive; lake forest, CA 92630 ; 9499001917
• MDR Report Key: 17567904
• Report Number: 3006135941-2023-00017
• Device Sequence Number: 20546671
• Product Code: CBK
• UDI-Device Identifier: 00860008873637
• UDI-Public: 00860008873637
• Combination Product (Y/N): N
• Initial Reporter Country: PA
• PMA/510(K) Number: K130178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 08/17/2023

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: INSPIRATION 7I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown