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

Model Number AF1140MB

Device Problem Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)

Event Type  malfunction  

Manufacturer Narrative

The customer alleges that "mask would not fit onto the connection port." no other details were provided and no patient injury/harm reported.Affected product was not returned nor was the lot number provided.The investigator could not confirm the customers claim without evaluating the actual affected device.An inventory evaluation was performed and the mask port deformation was not present in the inventory evaluation.

Event Description

The customer alleges that "mask would not fit onto the connection port." no other details were provided and no patient injury/harm reported.

Manufacturer Narrative

The affected device was returned and the mask fit onto the patient port easily.Customer complaint was not confirmed.Product functions as intended.

Event Description

The customer alleges that "mask would not fit onto the connection port." 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: 7885323
• MDR Text Key: 120560450
• Report Number: 1314417-2018-00030
• 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: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF1140MB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/20/2018
• Patient Sequence Number: 1