MAUDE Adverse Event Report: SUNMED HOLDINGS, LLC. AIRFLOW; MANUAL RESUSCITATOR

Model Number AF5140MB

Device Problem Fitting Problem (2183)

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

Event Date 12/23/2019

Event Type  malfunction  

Manufacturer Narrative

The customer noted that they had several occurences but the product was thrown away.No photographs were provided as evidence of the defect however, based on the described customer complaint, this is an ongoing issue that is being addressed per internal capa.

Event Description

The customer alleges that "mask is not fitting the bag properly." no other details were provided and no patient injury/harm reported.

• Brand Name: AIRFLOW
• Type of Device: MANUAL RESUSCITATOR
• Manufacturer (Section D): SUNMED HOLDINGS, LLC.; 2710 northridge dr. nw.; suite a; grand rapids MI 49544
• MDR Report Key: 9641933
• MDR Text Key: 221028620
• Report Number: 1314417-2020-00006
• 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
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF5140MB
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1