MAUDE Adverse Event Report: VENTLAB CORP. AIRFLOW RESUSCITATION BAG; MANUAL RESUSCITATOR

Model Number AFW1140MB

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

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

Event Date 06/14/2013

Event Type  Injury  

Event Description

The duckbill valve on the resuscitation bag is not opening.Not confirmed if this was during patient use.However, no death or serious injury reported.

Manufacturer Narrative

This belated mdr is being submitted as part of our remediation efforts in response to the fda form 483 notification issued on june 4, 2014 by (b)(4) to ventlab, llc.This effort consists of (b)(4) mdr's.The affected device was not investigated.However, ventlab performed quality trending, product investigation and corrective actions to solve the root causes.The solutions were implemented last year and a recall was initiated in may of this year.

• Brand Name: AIRFLOW RESUSCITATION BAG
• Type of Device: MANUAL RESUSCITATOR
• Manufacturer (Section D): VENTLAB CORP.; grand rapids MI
• Manufacturer Contact: rob yamashita ; 2710 northridge drive nw, ste a; grand rapids, MI 49544 ; 6162598373
• MDR Report Key: 4151554
• MDR Text Key: 20120529
• Report Number: 2246980-2014-00040
• 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: Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AFW1140MB
• Device Lot Number: 105819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention