MAUDE Adverse Event Report: AMBU USA AMBU SPUR 11 PEDIATRIC RESUSCITATOR; AMBU BAG

Model Number 064382010620

Device Problems Kinked (1339); Melted (1385); Defective Device (2588); Packaging Problem (3007)

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

Event Date 04/14/2016

Event Type  Injury  

Event Description

Pre-assembled pediatric ambu bag used for phase 1 recovery after anesthesia of pediatric patient in ambulatory surgical services did not allow for free flow of oxygen.The connector between the tubing and bag was kinked and appeared to have been a manufacturer defect.It appeared to have been melted within the package.

• Brand Name: AMBU SPUR 11 PEDIATRIC RESUSCITATOR
• Type of Device: AMBU BAG
• Manufacturer (Section D): AMBU USA; glen burnie MD 21060
• MDR Report Key: 5608468
• MDR Text Key: 43762017
• Report Number: MW5061878
• Device Sequence Number: 1
• Product Code: BTM
• UDI-Device Identifier: 00064382010620
• UDI-Public: 064382010620
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 064382010620
• Device Catalogue Number: 530 612 010
• Device Lot Number: 10007
• Is the Reporter a Health Professional?: Yes
• 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: 4 YR