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

Model Number AF5140MB

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

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

Event Date 04/29/2013

Event Type  Injury  

Event Description

Anesthesiologist could not get bag to squeeze.The one way valve was not opening.Doctor tried to perforate with a needle.

Manufacturer Narrative

This belated mdr is being submitted as part of our remediation reports in response to the fda form 483 notification issued on june 4, 2014 by (b)(4) to ventlab, llc.This report consists of 48 mdr's.Customer returned two units for investigation and malfunction was confirmed.Breakdown: one opened with less than 20cmh2o of pressure and the other opened with 55cmh2o of pressure.Additionally, 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 dr nw; ste a; grand rapids, MI 49544 ; 6162598373
• MDR Report Key: 4188102
• MDR Text Key: 5098172
• Report Number: 2246980-2014-00009
• 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: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AF5140MB
• Device Lot Number: 105709
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/05/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2013
• 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: RES68242
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention