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

Model Number AF1000

Device Problems Therapeutic or Diagnostic Output Failure (3023); Torn Material (3024)

Patient Problems Hypoxia (1918); Brain Injury (2219)

Event Date 11/02/2015

Event Type  Injury  

Event Description

"critical care team responded wo transfer patient to icu related to respiratory distress.Respiratory therapist unable to intubate, so began to use ambu bag.Respiratory therapist states that something happened to the flap on ambu bag rendering it useless.Patient placed on bipap while a nurse went to obtain another ambu bag patient continued to drop in oxygen saturation, so began to use ambu bag, and flap tore again.Patient was eventually intubated, but declared patient suffered hypoxic brain injury.".

• Type of Device: AIRFLOW RESUS BAG WITH MASK
• Manufacturer (Section D): VENTLAB LLC.; 2710 northridgedr. suite a; grand rapids MI 49544
• Manufacturer (Section G): VENTLAB LLC; 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: 5454292
• MDR Text Key: 38801051
• Report Number: 2246980-2015-00026
• 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: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: AF1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other