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

Model Number AF1140MB

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems No Code Available (3191); Missing Value Reason (3192)

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

The customer alleges that "a hole was found in the mask where it seals around the patient's nose and mouth." the customer returned affected product for evaluation.The product was returned used therefore the investigator was unable to fully evaluate the product due to the potential for contamination.Although the lot number was not reported an inventory evaluation was performed on two separate lots and no discrepancies or abnormalities were observed.

Event Description

The customer alleges that "hole found where it seals around the patient's nose and mouth." no other details were provided.

• Brand Name: AIRFLOW
• Type of Device: RESUS BAG
• 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: 7691413
• MDR Text Key: 114551071
• Report Number: 1314417-2018-00011
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: AF1140MB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR