MAUDE Adverse Event Report: VENTLAB LLC. VENTLAB; RESUS BAG

Model Number CPRM1116M

Device Problems Insufficient Information (3190); Missing Value Reason (3192)

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

Event Type  malfunction  

Manufacturer Narrative

The customer did not return the affected device to be evaluated and no lot number was provided.A nonconformance has been opened to further investigate the customer claims.

Event Description

The customer alleges that "mask will not connect to the resus bag." no other details were provided and no patient injury/harm reported.

• Brand Name: VENTLAB
• Type of Device: RESUS BAG
• Manufacturer (Section D): VENTLAB LLC.; 2710 northridge dr. suite a; grand rapids MI 49544
• Manufacturer (Section G): VENTLAB LLC.; 2710 northridge dr. suite a; grand rapids MI 49544
• Manufacturer Contact: carrie fortuna ; 2710 northridge dr. suite a; grand rapids, MI 49544 ; 6162598400
• MDR Report Key: 7013292
• MDR Text Key: 92609005
• Report Number: 2246980-2017-00029
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CPRM1116M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1