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

Device Problem Deflation Problem (1149)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2019

Event Type  Injury  

Event Description

While bagging the pt during a reintubation, the bag began to deflate, and o2 sat decreased from the high 90s down into the 40s.The bag was immediately replaced, sats improved and the intubation was successfully performed, tolerated well.No harm to pt.Respiratory therapy supv, medical supply team, and ambu rep aware.

• Brand Name: AMBU SPUR II
• Type of Device: VENTILATOR, EMERGENCY, MANUAL RESUSCITATOR
• Manufacturer (Section D): AMBU A/S
• MDR Report Key: 8274024
• MDR Text Key: 134137550
• Report Number: MW5083325
• Device Sequence Number: 0
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• 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): Required Intervention
• Patient Age: 55 YR