MAUDE Adverse Event Report: THE BAKER COMPANY BAKER BIOLOGICAL SAFETY CABINET; EQUIPMENT, LABORATORY,GENERAL PURPOSE,LABELED OR PROMOTED FOR A SPECIFIC MEDICAL

Model Number SG404

Device Problem Defective Alarm (1014)

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

Event Date 12/06/2019

Event Type  malfunction  

Event Description

Chemotherapy hood alarm malfunction.Alarm only shut off when window completely closed.Fda safety report id# (b)(4).

• Brand Name: BAKER BIOLOGICAL SAFETY CABINET
• Type of Device: EQUIPMENT, LABORATORY,GENERAL PURPOSE,LABELED OR PROMOTED FOR A SPECIFIC MEDICAL
• Manufacturer (Section D): THE BAKER COMPANY
• MDR Report Key: 9458576
• MDR Text Key: 170691150
• Report Number: MW5091603
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SG404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 DA