MAUDE Adverse Event Report: VENTLAB LLC. AIRFLOW; ADULT RESUS BAG WITH MANOMETER

Model Number AF1140MB

Device Problems Break (1069); Connection Problem (2900)

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

Event Date 05/14/2016

Event Type  malfunction  

Event Description

Per end user, "i had an incident sat.(b)(6) 2014 in which i was intubating a patient and after getting the ett placed, i tried to remove the mask and it was stuck.I continued to try to remove the mask without success, but eventually the plastic end broke off with the mask and so i was not able to ventilate the patient and needed someone to run and get me a new ambu bag." "i reproduced the incident with a new bag and found that when the mask is tightly attached to the bag the swivel is taken off with the mask unless the swivel is held to the bag.".

• Brand Name: AIRFLOW
• Type of Device: ADULT RESUS BAG WITH MANOMETER
• Manufacturer (Section D): VENTLAB LLC.; 2710 northridgedr. suite a; grand rapids MI 49544
• Manufacturer (Section G): VENTLAB LLC.; 2710 northridgedr. suite a; grand rapids MI 49544
• Manufacturer Contact: carrie fortuna ; 2710 northridge dr. suite a; grand rapids, MI 49544 ; 6162598350
• MDR Report Key: 5726896
• MDR Text Key: 48293127
• Report Number: 2246980-2016-00012
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF1140MB
• Device Lot Number: 304860
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1