MAUDE Adverse Event Report: CHART MVE BIOLOGICAL SYSTEMS INC CRYO PRESERVATION LIQUID NITROGEN FREEZER

Model Number XLC-1110

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 07/04/2019

Event Type  malfunction  

Event Description

A 160 degree freezer had a vacuum failure which caused it to lose its ability to maintain an appropriate temperature for specimens stored in the freezer.The vacuum failure was not identified until the freezer was opened for inspection.During this time temperatures were also being monitored with an isensix sensor.

• Brand Name: CRYO PRESERVATION LIQUID NITROGEN FREEZER
• Type of Device: LIQUID NITROGEN FREEZER
• Manufacturer (Section D): CHART MVE BIOLOGICAL SYSTEMS INC; 3505 county road 42 west; chart industries, applied technologies division; burnsville MN 53306 3803
• MDR Report Key: 9321085
• MDR Text Key: 166355993
• Report Number: 9321085
• Device Sequence Number: 1
• Product Code: LPZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: XLC-1110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/08/2019
• Device Age: 29 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1