MAUDE Adverse Event Report: VENTLAB AIR FLOW RESUSCITATION BAG

Model Number AF1000

Device Problems Failure to Deliver (2338); No Flow (2991)

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

Event Date 04/14/2014

Event Type  malfunction  

Event Description

(b)(4) resus bag is not deflating.

Manufacturer Narrative

The affected device was returned for investigation.Ventlab didn't analyze the affected device because corrective actions had already been identified and implemented at that time.Ventlab performed quality trending, product investigation and corrective actions to solve the root cause.A recall was initiated in (b)(6) 2014.

• Brand Name: AIR FLOW RESUSCITATION BAG
• Manufacturer (Section D): VENTLAB; grand rapids MI
• Manufacturer Contact: 2710 northridge drive nw ste a; grand rapids, MI 49544 ; 6162598373
• MDR Report Key: 4814449
• MDR Text Key: 5893843
• Report Number: 2246980-2015-00007
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AF1000
• Device Lot Number: 105588
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/02/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: RES 68242
• Patient Sequence Number: 1