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

Lot Number 1000608236

Device Problem Crack (1135)

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

Event Date 01/04/2023

Event Type  malfunction  

Event Description

Infant ambu bags found in stock with small crack where menometer hooks onto bag.

• Brand Name: RESUSCITATOR WITH MASK LF-NEO INFANT AMBU BAG
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): AMBU INC. / AMBU LIMITED
• MDR Report Key: 16138241
• MDR Text Key: 307199258
• Report Number: MW5114271
• Device Sequence Number: 1
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2023
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1000608236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1