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

Model Number AF1140MB-TM5

Device Problems Structural Problem (2506); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2018

Event Type  malfunction  

Manufacturer Narrative

No product was returned.The picture sent matches the mask deformation seen in previous masks in resuscitation bag assemblies.The mask ports are 100% inspected during assembly, this defect occurred during transit, due to the combination of heat during transit and pressure due to too little deadspace in the packaging.The time of manufacture meant that the box used was the j box, which had too short a box height.On 7/20/2018 was when co18-380 was implemented and switched this part number to c-s box, which has an extra couple inches height.

Event Description

The customer alleges that "mask connector is not round and will not connect to the elbow on the resus bag." 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: 7827861
• MDR Text Key: 118884679
• Report Number: 1314417-2018-00020
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• 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: 314829
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1