MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED; SMALL ADULT AIRFLOW W/MANOMETER

Model Number AF5140MB

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 12/15/2021

Event Type  Injury  

Manufacturer Narrative

The patient could not receive proper respiratory support and was reported to be unresponsive.Summary: the cutting process used for the patient valve duckbill is the likely root cause for the duckbill being sealed.On 5/10/2019, the drawing for the duckbill was updated to add a blade specification to reduce the material's ability to re-adhere after cutting.Ra: sealed duckbill has worst-potential severity of 9 - hazardous.This complaint will be brought to carb for review.However, risk is already mitigated significantly with in-process inspection requirements, blade specification added 5/10/2019, and ifu requirements to test the resuscitation bag prior to use.

Event Description

Duck bill sealed shut.Customer was unresponsive, used the af5140mb the duck bill valve would not allow the air to be squeezed out of it.Patient woke up afterwards.They tried again and with a lot of pressure it worked.

Manufacturer Narrative

The patient could not receive proper respiratory support and was reported to be unresponsive.Summary: the cutting process used for the patient valve duckbill is the likely root cause for the duckbill being sealed.On (b)(6) 2019, the drawing for the duckbill was updated to add a blade specification to reduce the material's ability to re-adhere after cutting.Ra: sealed duckbill has worst-potential severity of 9 - hazardous.This complaint will be brought to carb for review.However, risk is already mitigated significantly with in-process inspection requirements, blade specification added (b)(6) 2019, and ifu requirements to test the resuscitation bag prior to use.

Event Description

Duck bill sealed shut.Customer was unresponsive, used the af5140mb the duck bill valve would not allow the air to be squeezed out of it.Patient woke up afterwards.They tried again and with a lot of pressure it worked.

• Brand Name: SUNMED
• Type of Device: SMALL ADULT AIRFLOW W/MANOMETER
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand raids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 46544 ; 6162598415
• MDR Report Key: 13573204
• MDR Text Key: 289766659
• Report Number: 1314417-2022-00007
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AF5140MB
• Device Lot Number: 312679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 02/21/2022
• Supplement Dates Manufacturer Received: 12/15/2021
• Supplement Dates FDA Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other