MAUDE Adverse Event Report: SUNMED HOLDINGS LLC. AIRFLOW; MANUAL RESUSCITATOR

Model Number AF1140MB-TM5

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned, and the mask port was confirmed out of round via a visual inspection.The mask ports are 100% inspected during assembly therefore this defect occurred during transit due to previous packaging configurations.This product is prior to a new packaging configuration which used a slightly larger box and new packaging method to prevent mask ports from deforming.

Event Description

The customer alleges that "mask connection is out of round." no other details were provided and no patient injury/harm reported.

• Brand Name: AIRFLOW
• Type of Device: MANUAL RESUSCITATOR
• 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: 8936827
• MDR Text Key: 191468178
• Report Number: 1314417-2019-00045
• 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: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF1140MB-TM5
• Device Lot Number: 318170
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2019
• Type of Device Usage: N
• Patient Sequence Number: 1