MAUDE Adverse Event Report: VENTLAB LLC. AIRFLOW; RESUS BAG

Model Number AFW1140MB

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

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

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

Affected device returned and visually inspected.The returned device has been identified as product produced within the timeframe of our 2014 resus bag recall res 68242.First, visual inspection of the affected device demonstrated the material color of the diaphragms located at the opposite end of the manometer as green and red.We changed the color of all diaphragms to red on 26 jan 2015.Second, the affected device had a white pop-off cap below the integrated manometer.This was removed on 27 jan 2015.Third, the duckbill valve material was updated on 11 feb 2015.Review of the affected duckbill valve shows cavity designation as alphabetic "i".This cavity was used for the previous material.We conclude the affected device is from a lot number in the scope of recall res 68242.This recall was initiated on 08 may 2014 and deemed closed on 18 nov 2015.

Event Description

The customer alleges "the resus bag could not be squeezed and released as valve is sealed shut/not opening." no other details were provided and no patient injury/harm reported.

• Brand Name: AIRFLOW
• Type of Device: RESUS BAG
• Manufacturer (Section D): VENTLAB LLC.; 2710 northridgedr. suite a; grand rapids MI 49544
• Manufacturer (Section G): VENTLAB LLC.; 2710 northridgedr. suite a; grand rapids MI 49544
• Manufacturer Contact: carrie fortuna ; 2710 northridge dr. suite a; grand rapids, MI 49544 ; 6162598350
• MDR Report Key: 6310241
• MDR Text Key: 66772009
• Report Number: 2246980-2017-00007
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• PMA/PMN Number: K012842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AFW1140MB
• Device Lot Number: 306878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Removal/Correction Number: RES 68242
• Patient Sequence Number: 1