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

Model Number 8500

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918)

Event Date 10/04/2017

Event Type  Injury  

Event 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
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7185403
• MDR Text Key: 97066979
• Report Number: 3012307300-2018-00038
• Device Sequence Number: 1
• Product Code: BTM
• UDI-Device Identifier: 10351688431219
• UDI-Public: 10351688431219
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K014115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nursing Assistant
• Device Model Number: 8500
• Device Catalogue Number: 8500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 95