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

Model Number AF1140MB-P

Device Problem Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)

Event Date 08/04/2018

Event Type  malfunction  

Manufacturer Narrative

Customer did return affected devices and the investigator can confirm customer claim, a nonconformance has been opened to further investigate this defect.

Event Description

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

Event Description

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

Manufacturer Narrative

The mask port will fit onto the patient port with some force.The deformation of the mask port is caused by pressure, heat and time.The pressure is caused by too little deadspace in the box.The product was manufactured on 5/1/2018.The box used was g box (23 3/4 x 11 5/8 x 11).On (b)(6) 2018 a corrective action was implemented to change the box to c-1 (23 3/4 x 11 5/8 x 13) which increased the box height.

• Brand Name: AIRFLOW
• Type of Device: RESUS BAG
• Manufacturer (Section D): SUNMED HOLDINGS LLC.; 2710 northridge dr. nw; suite a; grand rapids MI 49544
• MDR Report Key: 7901811
• MDR Text Key: 121467512
• Report Number: 1314417-2018-00032
• 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
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF1140MB-P
• Device Lot Number: 314365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Patient Sequence Number: 1