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

Model Number AF1140MB

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems No Code Available (3191); Missing Value Reason (3192)

Event Date 08/15/2018

Event Type  malfunction  

Manufacturer Narrative

The affected device was returned and engineering was able to review the product through the packaging and determined that the mask port was deformed.The device was opened by engineering and was attempted to be attached to the valve patient port.Engineering determined that even though the mask port was out of round the mask was still able to be attached to the valve patient port without excessive force and created a good seal at the connection point.All masks processed through production are 100% inspected for this type of defect and would be scrapped if found during production.The defect is likely a result of transit/post processing.

Event Description

The customer alleges that "mask connector is mishappen." no other details were provided and no patient injury/harm reported.

• 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: 7863694
• MDR Text Key: 119799417
• Report Number: 1314417-2018-00026
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF1140MB
• Device Lot Number: 313930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1