MAUDE Adverse Event Report: VENTLAB AIRFLOW; RESUS BAG

Model Number AF1100MBS

Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

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

Event Date 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

The customer alleges that there was no valve or manometer in the bag." no other details were provided and no patient injury/harm reported.The affected device was not returned.Samples of the product were visually inspected from inventory all were confirmed with a manometer/valve attached to the bag and all components were present.The batch record was reviewed and there were no non-conformances.

Event Description

The customer alleges that " when ambu bag was opened it had the mask and bag, but no valve or manometer attached." no other details were provided and no patient injury/harm reported.

Manufacturer Narrative

Affected product was returned.The returned product was evaluated, and the missing patient valve with manometer was confirmed.All inventory is tested in line to ensure it functions before it is packaged.A bag missing the patient valve and manometer would be obvious to manufacturing personnel.A nonconformance has been opened to further investigate this defect.

Event Description

The customer alleged that "when ambu bag was opened it had the mask and bag, but no valve or manometer attached." 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
• MDR Report Key: 6973421
• MDR Text Key: 90791910
• Report Number: 2246980-2017-00026
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• PMA/PMN Number: K935633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF1100MBS
• Device Lot Number: 310403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2017
• Patient Sequence Number: 1