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

Model Number AF5140MB

Device Problem Inflation Problem (1310)

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

Event Date 10/04/2018

Event Type  malfunction  

Manufacturer Narrative

No product returned and inventory evaluation did not confirm the customer claim of deformed masks.Customer complaint was not confirmed.

Event Description

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

Manufacturer Narrative

Affected product was received after the initial mdr was submitted.Visual and functional testing was performed on the returned product.One mask was returned without the packaging and had the mask port deformation, however no lot number was included to confirm it was in the affected lot.This product was 100% inspected for this defect during packaging and none were found.Investigation is inconclusive.

Event Description

The customer alleges that "the mask is deformed." 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
• MDR Report Key: 8019919
• MDR Text Key: 126387492
• Report Number: 1314417-2018-00053
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF5140MB
• Device Lot Number: 315649
• Patient Sequence Number: 1