MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC GUARDIAN; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Catalog Number 65651-100

Device Problems Suction Problem (2170); Device Operates Differently Than Expected (2913)

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

Event Date 08/22/2016

Event Type  malfunction  

Event Description

The nurse was in a gallbladder case today and the suction stopped working.I looked at it and could see the lid was concave and i disconnected it and reconnected and it started working again.I was in a case last week when this happened and the irrigation was going all over the floor because the suction stopped.This has been a recurrent problem and can be very stressful when the surgeons cannot see what is happening during bleeding and the suction is malfunctioning.

• Brand Name: GUARDIAN
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 1500 waukegan rd; waukegan IL 60085
• MDR Report Key: 5989915
• MDR Text Key: 56023304
• Report Number: 5989915
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 65651-100
• Device Lot Number: J607-133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: SUCTION TUBING