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

Model Number AF5140MBS

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Type  malfunction  

Event Description

The customer reported "mask will not come off of the bag and "stem" is breaking when trying to remove, leaving no way to ventilate via tube.One patient had to be extubated because the "stem broke." no other details were provided and no patient injury/harm reported.

• Brand Name: AIRFLOW
• Type of Device: RESUS BAG
• 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: 5893828
• MDR Text Key: 53608809
• Report Number: 2246980-2016-00034
• 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: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF5140MBS
• Device Lot Number: 305350
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention