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

Model Number AF5140MBP

Device Problem Deflation Problem (1149)

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

Event Date 01/31/2017

Event Type  malfunction  

Manufacturer Narrative

The affected device was not returned for evaluation.The customer was not able to provide the actual lot number of the affected device.The lot number that was provided was from a comparable product.This comparable product was approximately 2 years old.Storage conditions for an extended period like 2 years can contribute to loss of inflation.This mask is equipped with a tail valve for quick and easy re-inflation with a syringe should more inflation be needed.There is no indication that this action was taken.Based on the information provide there is no way to know if the mask was deflated because of a defect such as a hole or tear or if there was a general loss of inflation for other reasons such as storage conditions.

Event Description

The customer alleges "the mask on the resus bag was deflated." 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: 6365384
• MDR Text Key: 69015081
• Report Number: 2246980-2017-00010
• 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: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF5140MBP
• Device Lot Number: 300254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1