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

Lot Number 1000804646

Device Problems Inflation Problem (1310); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2023

Event Type  malfunction  

Event Description

Ambu bag did not work during an intubation.Oxygen was flowing, reservoir did initially inflate, but would not stay inflated and did not deliver oxygen to patient.When attempting to deliver a breath, the ambu bag itself had no pressure when squeezed.It would just deflate.All connections were checked and were intact.Quickly opened a second bag and the same thing happened.Third bag was operational.

• Brand Name: AMBU SPUR II ADULT RESUSCITATOR SINGLE PATIENT USE RESUSCITATOR
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): AMBU A/S; 6721 columbia gateway drive, suite 200; columbia MD 21046
• MDR Report Key: 17315711
• MDR Text Key: 318940514
• Report Number: 17315711
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 1000804646
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Sex: Male