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

Model Number AF5140MC

Device Problem Break (1069)

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

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

The returned devices were confirmed to be broken upon receiving inspection. The customer did not provide enough detail to determine when the damage occurred. This type of damage is believed to be a result of blunt force such as a drop or transit damage. Based on the lot dates of the product returned this is likely product that was not within new and improved divided boxes that help protect product from this type of damage. The customer complaint is confirmed.

Event Description

The customer alleges that "resuscitators are breaking. " 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
• MDR Report Key: 9746436
• Report Number: 1314417-2020-00012
• 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
• Source Type: distributor
• Type of Report: Initial
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: AF5140MC
• Device Lot Number: 318655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage