MAUDE Adverse Event Report: BODY VISION MEDICAL LTD. LUNGVISION SYSTEM; System, image processing, radiological

Model Number	LV105502
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Though the device malfunctioned, the clinician was able to perform biopsies with no injury to the patient.However, because of the hardware error, the patient probably experienced a delay in the procedure which caused them to have additional exposure time to radiation and additional time under anesthesia.Thus, in conclusion, though the hardware malfunctioned and caused additional time under anesthesia and additional exposure to radiation body vision medical ltd.Is filing this adverse event report in an abundance of caution.
Event or Problem Description
During the procedure the computer power was repeatedly lost.The user lost lesion image and location and could not continue sampling from the accurate location.Biopsies were taken but the case was eventually aborted and not finished as planned.

• Brand Name: LUNGVISION SYSTEM
• Common Device Name: System, image processing, radiological
• Manufacturer (Section D): BODY VISION MEDICAL LTD.; 7 hamada st.; herzliya, 46733 41; IS 4673341
• Manufacturer (Section G): BODY VISION MEDICAL LTD.; 7 hamada st.; herzliya, 46733 41; IS 4673341
• Manufacturer Contact: benny krauz ; 7 hamada st.; herzliya, 46733-41 ; IS 4673341
• MDR Report Key: 15914881
• Report Number: 3014491269-2022-00003
• Device Sequence Number: 14552163
• Product Code: LLZ
• UDI-Device Identifier: 07290017652085
• UDI-Public: 7290017652085
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K183593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2022

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: LV105502
• Device Lot Number: LVS21002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown