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

Model Number AAF1140MB

Device Problems Sticking (1597); Material Integrity Problem (2978)

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

Event Date 07/06/2016

Event Type  malfunction  

Event Description

Recently the clinical staff has noticed some difficulty detaching the masks from the valve of the resuscitator bag.As we examined the product more closely we identified that as of (b)(6) of this year, it appears there has been revision to the current brand product ((b)(4)) that we have been receiving.Apparently with this current batch of revision# 10 that we have received the attachment for the mask gets stuck and it is difficult at times for the end-users to detach it from the bag.In one instance, a clinician was having difficulty and when he attempted to exert more force it resulted in damage to the valve rendering the bag inoperable.

• 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: 5846095
• MDR Text Key: 52421453
• Report Number: 2246980-2016-00023
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• 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: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AAF1140MB
• Device Lot Number: 304805 & 304652
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2016
• Type of Device Usage: N
• Patient Sequence Number: 1