MAUDE Adverse Event Report: VENTLAB, LLC AIRFLOW ADULT RESUSCITATOR; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Catalog Number AF1140MB-P

Device Problems Difficult to Open or Remove Packaging Material (2922); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2016

Event Type  malfunction  

Event Description

During a cardiac arrest the bag valve mask (bvm) was used to ventilate.Anesthesia decided to intubate patient and when the anesthesiologist attempted to place the endotracheal tube (ett) the mask would not separate from the bvm- therefore unable to attach to ett.Staff located a second bag which was a different lot.No known harm to patient.Manufacturer response for ambu bag, airflow adult resuscitator with manometer, filter, mask , bag and peep valve (per site reporter): we have removed all affected lot numbers manufacturer rep shared that there was a minor change on mask production to reduce waste that caused the hub of the mask to stick and made it almost impossible to remove from the rest of the bag.

• Brand Name: AIRFLOW ADULT RESUSCITATOR
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): VENTLAB, LLC; 2710 northridge dr. n.w. ste a; grand rapids MI 49544
• MDR Report Key: 6102548
• MDR Text Key: 59909429
• Report Number: 6102548
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: AF1140MB-P
• Device Lot Number: 304948- 305780
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1