MAUDE Adverse Event Report: AMBU LIMITED RESUSCITATOR WITH MASK LF-NEO INFANT AMBU BAG; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Lot Number 1000686848

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 01/04/2023

Event Type  malfunction  

Event Description

The respiratory team noticed that some of the infant ambu bag have a small crack where manometer hooks on to the bag.

• Brand Name: RESUSCITATOR WITH MASK LF-NEO INFANT AMBU BAG
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): AMBU LIMITED; columbia
• MDR Report Key: 16121861
• MDR Text Key: 306997656
• Report Number: MW5114219
• Device Sequence Number: 5
• 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: 01/04/2023
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 1000686848
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose