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

Catalog Number SEE1000

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2016

Event Type  malfunction  

Event Description

The swivel part became detached, attempted to replace the swivel but it continued to happen.

• Brand Name: PATRIOT
• Type of Device: RESUS BAG
• Manufacturer (Section D): VENTLAB LLC.; 2710 northridgedr. suite a; grand rapids MI 49544
• Manufacturer (Section G): VENTLAB LLC.; 2710 northridgedr. suite a; grand rapids MI 49544
• Manufacturer Contact: carrie fortuna ; 2710 northridge dr. suite a; grand rapids, MI 49544 ; 6162598350
• MDR Report Key: 5741489
• MDR Text Key: 48714655
• Report Number: 2246980-2016-00018
• 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: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: SEE1000
• Device Lot Number: 305478
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2016
• Type of Device Usage: N
• Patient Sequence Number: 1