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

Model Number AF5140MB

Device Problem Inflation Problem (1310)

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

Event Type  malfunction  

Manufacturer Narrative

No event date was provide as well as no picture or product returned.Inventory evaluation of product did not confirm complaint.Investigation is inconclusive.

Event Description

The customer alleges the "air mask cannot be inflated." no other details were provided and no patient injury/harm reported.

Event Description

The customer alleges the "air mask cannot be inflated." no other details were provided and no patient injury/harm reported.

Manufacturer Narrative

One of the affected devices where returned.The mask valve functioned as intended when an inflation bulb was used.The mask was inflated and had no leakage.Complaint could not be confirmed.

• 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: 8603201
• MDR Text Key: 145113817
• Report Number: 1314417-2019-00025
• 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: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• 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: 315382
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1