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

Model Number AF5140MB

Device Problem Misconnection (1399)

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

Event Type  malfunction  

Manufacturer Narrative

No picture or product returned.Inventory evaluation of product did not confirm complaint.Investigation is inconclusive.

Event Description

The customer alleges the "warped mask will not connect to resuscitator".No other details were provided and no patient injury/harm reported.

Manufacturer Narrative

One each was returned with the mask connected to the patient valve.When the mask was removed from the patient valve, the mask connected to the patient valve easily and stayed in place.Complaint not confirmed.

Event Description

The customer alleges the "warped mask will not connect to resuscitator." 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: 8605302
• MDR Text Key: 149357736
• Report Number: 1314417-2019-00026
• 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: 07/10/2019

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: 35382
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1