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

Model Number AF1140MB-P

Device Problems Device Issue (2379); Separation Failure (2547); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

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

Event Type  malfunction  

Manufacturer Narrative

An extensive and thorough investigation was performed by the engineering team that concluded the root cause for this problem is the fact that the patient port and the mask are made out of similar base materials resulting in an undesirably high coefficient of friction between the two parts.Steps have been taken to implement a material combination with a lower coefficient of friction that significantly reduces the effort required to remove the mask from the patient valve.

Event Description

The customer alleges " that removing the mask from the swivel is difficult and they had to use a whole new set up." 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: 5937036
• MDR Text Key: 54272638
• Report Number: 2246980-2016-00040
• 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: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF1140MB-P
• Device Lot Number: 302620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1