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

Catalog Number AF5140MB

Device Problem Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2022

Event Type  malfunction  

Event Description

Rrt (respiratory therapist) was called to the bedside (unv ed north 20) for assistance of intubation of a patient.Rrt gathered all necessary equipment and checked to ensure functionality of equipment including bag valve mask and ventilator.Patient was intubated by resident and bvm (bag valve mask) was placed on patient at which time it malfunctioned, failing to deliver volume to the patient.Bvm was taken off the patient and patient placed on the ventilator where they were successfully ventilated without issue.

• Brand Name: AIRFLOW, VENTLAB
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): SUNMED HOLDINGS, LLC; 2710 northridge drive nw, suite a; grand rapids MI 49544
• MDR Report Key: 15619260
• MDR Text Key: 301909763
• Report Number: 15619260
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2022,09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: AF5140MB
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Sex: Male
• Patient Race: White