MAUDE Adverse Event Report: VENTLAB AIRFLOW; RESUS BAG

Model Number AF1140MB

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

Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

The affected device was returned.Functional testing of the device was performed and no abnormalities were observed.A visual inspection of the device was also performed and the following was observed: the product contained a white cap, the current product revision contains either a pop off valve or no cap.Additionally the returned product contained a green diaphragm valve seated within the tail end of the resus bag body in place of the current product's design which contains a red diaphragm valve.The white cap change was effective (b)(6) 2015 per (b)(4).The diaphragm valve color change was effective (b)(6) 2015 per (b)(4).These two visual indicators indicate that the product was manufactured prior to january 2015, using the old design components and therefore could not be the lot number that was reported by the end user.If the product was manufactured prior to january 2015 as supported by the visual indicators above, the product would also contain an old-design duckbill.The duckbill was re-designed and implemented in (b)(6) 2015 per (b)(4).The re-design of the duckbill was performed to change the material.This change was implemented due to prior customer complaints, sunmed capa(b)(4) and subsequent recall (dated (b)(6) 2014) for sticking/stuck duckbill and through validation (b)(4) demonstrated that the change corrected the sticking/stuck duckbill defect.Therefore, this device is believed to have been within the scope of the mentioned recall that was inadvertently not returned by the end user.

Event Description

The customer alleges that " the duckbill valve was sticking." no other details were provided and no patient injury/harm reported.

• Brand Name: AIRFLOW
• Type of Device: RESUS BAG
• Manufacturer (Section D): VENTLAB; 2710 northridge dr. suite a; grand rapids MI 49544
• Manufacturer (Section G): VENTLAB; 2710 northridge dr. suite a; grand rapids MI 49544
• Manufacturer Contact: carrie fortuna ; 2710 northridge dr. suite a; grand rapids, MI 49544 ; 6162598400
• MDR Report Key: 7508273
• MDR Text Key: 108264730
• Report Number: 2246980-2018-00004
• 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: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF1140MB
• Device Lot Number: 312332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1