MAUDE Adverse Event Report: AMBU A/S SPUR II INFANT; MANUAL EMERGENCY VENTILATOR

Model Number 335009000

Device Problem Gas/Air Leak (2946)

Patient Problem Hypoxia (1918)

Event Date 10/07/2022

Event Type  malfunction  

Event Description

The child (b)(6) was in a very serious state (bronchospasm), under non-invasive ventilation.Upon arrival, resuscitation with spur ii resuscitator was initiated.The spur presented leaks around the connection with the facemask.As a result the infant had to be intubated.

• Brand Name: SPUR II INFANT
• Type of Device: MANUAL EMERGENCY VENTILATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer Contact: joost venner ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 15728130
• MDR Text Key: 307122589
• Report Number: 9610691-2022-00014
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 335009000
• Device Catalogue Number: 335009000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1