MAUDE Adverse Event Report: SUNMED HOLDINGS, LLC. AIRFLOW; RESUS BAG

Model Number AF1140MB-N

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Based on the photos provided by the customer of the new gces medivital valve and the email correspondence indicates there were no defects with the resuscitation bags, the device functioned as intended.On the gce medivital valve, there is a grey ridge or lip on the valve that prevents the universal connector from making a connection.The universal connector is not compatible with the new gce medivital valve.The end connector complies with bs en 13544-2 respirator therapy equipment - part 2: tubing and connectors.

Event Description

The customer alleges that "airflow bag tubing connector coming unattached from the oxygen tank." no other details were provided.

• Brand Name: AIRFLOW
• Type of Device: RESUS BAG
• 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 rapids MI 49544
• Manufacturer Contact: carrie fortuna ; 2710 northridge dr. nw.; suite a; grand rapids, MI 49544 ; 6162598400
• MDR Report Key: 9186863
• MDR Text Key: 207000875
• Report Number: 1314417-2019-00057
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF1140MB-N
• Type of Device Usage: N
• Patient Sequence Number: 1