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

Model Number AF5140MB-M5

Device Problems Appropriate Term/Code Not Available (3191); Missing Value Reason (3192)

Patient Problems Not Applicable (3189); Missing Value Reason (3192)

Event Type  malfunction  

Manufacturer Narrative

(b)(4) masks were returned, inspected and found to be slightly deformed.(b)(4) of the masks were still easy to attach to a patient valve and the other (b)(4) masks took a conscious effort to attach the mask to the patient valve.The manufacturing and inspection records were reviewed and there were no related issues found.All product was manufactured and tested per product specifications.

Event Description

The customer alleges "the stem of the mask is out of round and they cannot attach the mask to the bag." 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: 6105385
• MDR Text Key: 59974336
• Report Number: 2246980-2016-00068
• 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
• Type of Report: Initial
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF5140MB-M5
• Device Lot Number: 306432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1