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

Catalog Number AF5140MBP-I

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

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

Event Date 03/27/2015

Event Type  malfunction  

Event Description

Went to use the bag and the duckbill valve was sealed shut.Realized it did not work and pulled another bag for use on patient.

Manufacturer Narrative

The affected device was returned for investigation.However, we confirmed that the duckbill valve was partially opened.However, this device was still able to provide enough air that the device functioned as intended.Ventlab performed quality trending, product investigation and corrective actions to solve the root causes.This is reflected in the evaluation.A recall was initiated in (b)(6) 2014.

• Brand Name: AIR FLOW RESUSCITATION BAG
• Type of Device: MANUAL RESUSCITATOR
• Manufacturer (Section D): VENTLAB CORP.; grand rapids MI
• Manufacturer Contact: rob yamashita ; 2710 northridge dr. nw; ste a; grand rapids, MI 49544 ; 6162598373
• MDR Report Key: 4755226
• MDR Text Key: 5770959
• Report Number: 2246980-2015-00004
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AF5140MBP-I
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: RES68242
• Patient Sequence Number: 1