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

Catalog Number 8520

Device Problems Component Missing (2306); Output Problem (3005)

Patient Problem No Code Available (3191)

Event Date 07/28/2014

Event Type  malfunction  

Event Description

Patient arrived to pacu from undergoing a bmtt (bilateral myringotomies with touma tympanostomy tube insertions) and adenoidectomy; the patient was extubated in the surgical suite prior to pacu arrival.Shortly after arriving to the pacu, the patient experienced larynogospasm.Immediate attempts to ventilate the patient with bag/mask were unsuccessful as the mask would not provide an adequate seal for ventilation with the amount of air in the mask; the mask did not have a valve to allow additional air to be added to meet the contours of the patient's face.The patient was re-intubated and monitored for a period of time before eventual extubation and discharge.

• Brand Name: PORTEX 1ST RESPONSE
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 1265 grey fox rd; st.paul MN 55112
• MDR Report Key: 4005134
• MDR Text Key: 4706607
• Report Number: 4005134
• Device Sequence Number: 1
• Product Code: BTM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 8520
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2014
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/13/2014
• Patient Sequence Number: 1
• Patient Age: 4 YR