MAUDE Adverse Event Report: AMBU A/S AMBU SPUR II ADULT RESUSCITATOR; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number PACKAGING UNAVAILABLE

Device Problem Component Missing (2306)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/14/2022

Event Type  Injury  

Event Description

Patient was being resuscitated with ambu bag/mask prior to intubation.Due to oxygen saturation levels being low, a second ambu was obtained.The patient was adequately ventilated by the second ambu bag/mask.Upon inspection of the ambu after the code, it was discovered that the exhalation valve was missing on the first ambu.This missing valve may have contributed in the low saturation level resulting from inadequate resuscitation.Fda safety report id# (b)(4).

• Brand Name: AMBU SPUR II ADULT RESUSCITATOR
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): AMBU A/S; cn; DA
• MDR Report Key: 13334012
• MDR Text Key: 284375643
• Report Number: MW5106892
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PACKAGING UNAVAILABLE
• Device Catalogue Number: PACKAGING UNAVAILABLE
• Device Lot Number: 1000527568
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 35 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White