MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® 1ST RESPONSE¿ ADULT MANUAL RESUSCITATORS; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number	8500
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918)
Date of Event	10/04/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that about 3-4 minutes into a transesophageal echocardiography (tee) procedure this 1st response manual resuscitator became disconnected from the oxygen wall regulator.This caused the patient's oxygen saturation level (spo2) to drop into the 70 percent range and their heart rate to drop to around 30 beats per minute.The oxygen was reconnected and the patient was ventilated with a manual resuscitator.10 mcg of epinephrine was administered and the tee probe was removed.A code blue was called for pulseless electrical activity arrest.Cpr was initiated with return of spontaneous circulation after approximately 2-3 minutes.The procedure was abandoned and the patient was admitted to the cardiovascular intensive care unit and placed on a ventilator.It was noted that no one had pulled on the tubing causing the dislodgement from the oxygen wall regulator during the procedure.It was also noted that the oxygen wall regulator was behind the certified nursing assistant managing the 1st response manual resuscitator thus the dislodgement was not immediately recognized.No additional adverse patient effects were reported.

• Brand Name: PORTEX® 1ST RESPONSE¿ ADULT MANUAL RESUSCITATORS
• Common Device Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7185403
• Report Number: 3012307300-2018-00038
• Device Sequence Number: 1447543
• Product Code: BTM
• UDI-Device Identifier: 10351688431219
• UDI-Public: 10351688431219
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K014115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/12/2018

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: Nursing Assistant
• Device Model Number: 8500
• Device Catalogue Number: 8500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 95