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

Model Number AF1140MBSP-I

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

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

Event Date 12/03/2013

Event Type  Injury  

Event Description

The membrane inside of the inspiratory valve, inside the adult manual resuscitator is sealed, not allowing air to flow into the patient's airway.The manual resuscitator is unable to be squeezed in an effort to ventilate to patient.No serious injury or death 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 48 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; grand rapids MI
• Manufacturer Contact: rob yamashita ; 2710 northridge dr. nw; grand rapids, MI 49544 ; 6162598373
• MDR Report Key: 4188088
• MDR Text Key: 5160626
• Report Number: 2246980-2014-00026
• 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: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AF1140MBSP-I
• Device Lot Number: 105828
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2013
• Initial Date FDA Received: 09/19/2014
• 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
• Patient Outcome(s): Required Intervention