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

Catalog Number AF1140MB

Device Problem Hole In Material (1293)

Patient Problem Death (1802)

Event Date 06/12/2018

Event Type  malfunction  

Event Description

Hole found in bag valve mask where it seals around patient's nose and mouth.When code blue was initiated on patient, the mask was pulled from the crash cart and staff was unable to create a seal.It was quickly found that there was a large hole where the seal should be created around the patient's mouth and nose.A new mask was obtained to assist with ventilation until code team arrived and intubated the patient.Unfortunately the patient did expire, but the mask did not play a role in it.I am unsure what the process is for how/if equipment is checked before it is placed into the crash cart.The equipment manager responded with: equipment does not use any knives or anything so they would not have cut it.It must have been a defect in product.If the packaging itself had a hole or tear in it, they would have not placed the product in the crash cart.Per site reporter: i contacted customer service at (b)(4) and they are sending me a complaints form and a shipping label to send the mask back.I will also send a picture.

Event Description

Hole found in bag valve mask where it seals around patient's nose and mouth.When code blue was initiated on patient, the mask was pulled from the crash cart and staff was unable to create a seal.It was quickly found that there was a large hole where the seal should be created around the patient's mouth and nose.A new mask was obtained to assist with ventilation until code team arrived and intubated the patient.Unfortunately the patient did expire, but the mask did not play a role in it.I am unsure what the process is for how/if equipment is checked before it is placed into the crash cart.The equipment manager responded with: equipment does not use any knives or anything so they would not have cut it.It must have been a defect in product.If the packaging itself had a hole or tear in it, they would have not placed the product in the crash cart.Per site reporter: i contacted customer service at ventlab and they are sending me a complaints form and a shipping label to send the mask back.I will also send a picture.

• Brand Name: AIRFLOW
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): SUNMED; 2710 northridge drive nw suite a; grand rapids MI 49544
• MDR Report Key: 7638155
• MDR Text Key: 112346784
• Report Number: 7638155
• 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,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AF1140MB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22995 DA