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

Model Number AF5140MB

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Manufacturer Narrative

The customer did not provide a photograph, lot number or physical product to review.The customer's complaint description suggests that sunmed never provided the customer with a mask in the resuscitation kit.There is no evidence available to confirm the customers complaint as an inventory analysis from a part number within the same family concluded that all components including a mask were in the kit drawstring bag.

Event Description

The customer alleges that " resus bag is missing the mask." 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
• Manufacturer (Section G): SUNMED HOLDINGS LLC.; 2710 northridge dr. nw; suite a; grand rapids MI 49544
• Manufacturer Contact: carrie fortuna ; 2710 northridge dr. nw.; suite a; grand rapids, MI 49544 ; 6162598400
• MDR Report Key: 9416639
• MDR Text Key: 191467747
• Report Number: 1314417-2019-00059
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: AF5140MB
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1