MAUDE Adverse Event Report: FOLLETT LLC REFRIGERATOR; REFRIGERATOR, FREEZER, BLOOD STORAGE

Model Number REF5

Device Problem Excessive Cooling (2932)

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

Event Date 07/21/2019

Event Type  malfunction  

Event Description

There is a problem with the temperature control causing this pharmaceutical grade model refrigerator to become a freezer.We have an external monitoring system that graphs the temperature dropping too cold.We have been able to prevent product loss at times, but have also lost medications several times due to this fault.

• Brand Name: REFRIGERATOR
• Type of Device: REFRIGERATOR, FREEZER, BLOOD STORAGE
• Manufacturer (Section D): FOLLETT LLC; 801 church lane; easton PA 18040
• MDR Report Key: 9097504
• MDR Text Key: 159351239
• Report Number: 9097504
• Device Sequence Number: 1
• Product Code: KSE
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: REF5
• Device Catalogue Number: REF5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1