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

Catalog Number 520211000

Device Problem Deflation Problem (1149)

Patient Problem Hypoventilation (1916)

Event Date 09/03/2020

Event Type  Injury  

Event Description

Ambu bag valve mask would not was deflated and would inflate to be able to provide rescue breathing to patient.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
• MDR Report Key: 10540716
• MDR Text Key: 207358197
• Report Number: MW5096666
• Device Sequence Number: 1
• Product Code: BTM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 520211000
• Device Lot Number: 1673030
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 29 YR
• Patient Weight: 57