MAUDE Adverse Event Report: VENTLAB MEDLINE; RESUS BAG

Model Number CPRM1116M

Device Problems Device Issue (2379); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

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

Event Date 09/30/2017

Event Type  malfunction  

Manufacturer Narrative

The customer alleges that there is a "faulty valve causing a leak in the resus bag" no other details were provided and no patient injury/harm reported.The customer did not return any product to be evaluated however they did provide photos.Based on the photographs, engineering can determine that the red diaphragm valve appears to be defective.Although photographic evidence is provided the photographs do not show enough detail, this makes it hard to determine the cause of the defect.

Event Description

The customer alleges that there is a "faulty valve causing a leak in the resus bag" no other details were provided and no patient injury/harm reported.

• Brand Name: MEDLINE
• Type of Device: RESUS BAG
• Manufacturer (Section D): VENTLAB; 2710 northridge dr.; suite a; grand rapids MI 49544
• Manufacturer (Section G): VENTLAB; 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: 6986614
• MDR Text Key: 91134685
• Report Number: 2246980-2017-00027
• 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
• Report Date: 10/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• 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
• Date Manufacturer Received: 10/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1