MAUDE Adverse Event Report: VENTLAB VENTLAB; RESUS BAG

Model Number VN1000MBPF-I

Device Problem Hole In Material (1293)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 04/28/2017

Event Type  malfunction  

Manufacturer Narrative

The device did exhibit a hole in the resus bag, however the product manufacturing date is june of 2007.Due to how old the product is, stress cracks are visible and most likely formed due to the length of time the product was in the field.Currently standard age testing performed by sunmed is 5 years on silicone bags and are given a 5 year shelf life.The 1000 series product has since been obsolete and is no longer available.

Event Description

The customer alleges "patient coded and the nurse used the product and there was a hole in bag and caused further complications." no other details were provided.

• Brand Name: VENTLAB
• 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: 6597668
• MDR Text Key: 76273326
• Report Number: 2246980-2017-00019
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: VN1000MBPF-I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2007
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 127