MAUDE Adverse Event Report: GIVEN IMAGING VIETNAM CO LTD VERSAFLEX; ELECTRODE, PH, STOMACH

Model Number	900004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiogenic Shock (2262); Blood Loss (2597)
Date of Event	02/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the patient was (b)(6) year old undergone an egd with propofol, they placed the patient to supine and placed the ph impedance catheter.They were having trouble intubating and they moved back and forth and there was a significant amount of nasal bleeding that happened and the patient also had laryngospasm and the ph level dropped to 15% below baseline causing them to open the crash cart and begun bagging the patient.There was no patient injury.

• Brand Name: VERSAFLEX
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING VIETNAM CO LTD; suite 6a, 6th floor; ho chi minh city
• MDR Report Key: 7375791
• Report Number: 3007662958-2018-00001
• Device Sequence Number: 13814503
• Product Code: FFT
• UDI-Device Identifier: 04260167482323
• UDI-Public: 04260167482323
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/21/2018
• Device Model Number: 900004
• Device Catalogue Number: 900004
• Device Lot Number: F1748101UA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 9 YR