MAUDE Adverse Event Report: AMBU A/S AMBU KING MASK/DISPOSABLE ANESTHESIA FACE MASK; MASK, GAS, AHESTHETIC

Lot Number	1000181222
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During resuscitation cpap mask went completely flat, making it extremely difficult to maintain a seal for infant.Prior to delivery, mask was checked by 3 nurses including this rn and the nicu rn.

• Brand Name: AMBU KING MASK/DISPOSABLE ANESTHESIA FACE MASK
• Common Device Name: MASK, GAS, AHESTHETIC
• Manufacturer (Section D): AMBU A/S; ballerup.dk
• MDR Report Key: 8343158
• Report Number: MW5084075
• Device Sequence Number: 11027369
• Product Code: BSJ
• UDI-Device Identifier: 00612649184777
• UDI-Public: (01)00612649184777
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2021
• Device Lot Number: 1000181222
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Weight: 3