MAUDE Adverse Event Report: VENTLAB AIRFLOW RESUSCITATION BAG; MANUAL RESUSCITATOR

Model Number BT4018

Device Problems Failure to Deliver (2338); No Flow (2991)

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

Event Date 04/25/2014

Event Type  Injury  

Event Description

A (b)(6) yr old male had undergone an adenoidectomy and was under general anesthesia.Pt developed laryngospasms and experienced cardiac arrest.The healthcare professional used the resuscitation bag and it didn't work.A second bag was attempted and didn't work.A third bag was used successfully.

• Brand Name: AIRFLOW RESUSCITATION BAG
• Type of Device: MANUAL RESUSCITATOR
• Manufacturer (Section D): VENTLAB; 2710 northridge dr nw; ste a; grand rapids MI 49544
• Manufacturer Contact: debbie daly ; 2710 northridge dr nw; ste a; grand rapids, MI 49544 ; 6162598372
• MDR Report Key: 3890770
• MDR Text Key: 4673523
• Report Number: 2246980-2014-00002
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BT4018
• Device Lot Number: 106343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: RES 68242
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention