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

Model Number AF5140MB-S

Device Problems Air Leak (1008); Failure to Deliver (2338)

Patient Problem Death (1802)

Event Date 08/09/2016

Event Type  Death  

Manufacturer Narrative

Sunmed investigated the affected device and was unable to replicate the fracture characteristics of the stem failure mode.Dimensional and visual inspection of the components and tools did not indicate an damage or excessive wear.During the investigation diaphragms were intentionally damaged, but the product still performed as intended.Additionally, we performed a historical customer complaint review (external data) and a nonconforming product review (internal data) and found no occurrences of this failure mode.We have not been able to determine the root cause and consider this to be an isolated incident.

Event Description

The customer alleges " air was escaping from the back of the resus bag and was not being delivered through the mask to the patient.".

• Brand Name: AIRFLOW
• Type of Device: RESUS BAG
• Manufacturer (Section D): VENTLAB LLC.; 2710 northridgedr. suite a; grand rapids MI 49544
• Manufacturer (Section G): VENTLAB LLC.; 2710 northridgedr. suite a; grand rapids MI 49544
• Manufacturer Contact: rob yamashita ; 2710 northridge dr. suite a; grand rapids, MI 49544 ; 6162598350
• MDR Report Key: 5924588
• MDR Text Key: 53811248
• Report Number: 2246980-2016-00038
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: AF5140MB-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death