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

Model Number AF1000

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

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

Event Date 11/04/2013

Event Type  malfunction  

Event Description

We became aware of an issue by a system hospital that they found a duck valve that got stuck while trying to use a resuscitation bag valve mask.We checked our supplies and found (b)(4) defective valves.With some extra pressure the valve will release, but in a code situation these valves could pose a risk.

Manufacturer Narrative

(b)(4).The affected device was not returned and 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; grand rapids MI
• Manufacturer Contact: rob yamashita ; 2710 northridge drive ne; suite a; grand rapids, MI 49544 ; 6162598373
• MDR Report Key: 4360553
• MDR Text Key: 17936131
• Report Number: 2246980-2014-00065
• 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: Risk Manager
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AF1000
• Device Catalogue Number: AF1000
• Device Lot Number: 106564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2013
• 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
• Removal/Correction Number: RES68242
• Patient Sequence Number: 1