MAUDE Adverse Event Report: ENVIZION MEDICAL, LTD. ENVUE FEEDING TUBE PLACEMENT SYSTEM; NG FEEDING TUBE

Model Number	ENV-20000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023 envizion was made aware that a lung placement occurred on (b)(6) 2023 and caused the patient to desat with spo2 diving down as low as 58%.
Event or Problem Description
On (b)(6) 2023 envizion was made aware that a lung placement occurred on 11jul2023 and caused the patient to desat with spo2 diving down as low as 58%.

• Brand Name: ENVUE FEEDING TUBE PLACEMENT SYSTEM
• Common Device Name: NG FEEDING TUBE
• Manufacturer (Section D): ENVIZION MEDICAL, LTD.; 26 habarzel; tel aviv, il 69710 36; IS 6971036
• Manufacturer (Section G): ERI GROUP INC.; 433 park point dr.; golden CO 80401
• Manufacturer Contact: john mann ; 26 habarzel st.; tel-aviv, israel 69710-36 ; IS 6971036
• MDR Report Key: 17513394
• Report Number: 3011548489-2023-00003
• Device Sequence Number: 5576251
• Product Code: KNT
• UDI-Device Identifier: B483EVN200000
• UDI-Public: B483EVN200000
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ENV-20000
• Device Catalogue Number: ENV-20000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male