MAUDE Adverse Event Report: HELMER, INC. I.SERIES; REFRIGERATOR, FREEZER, BLOOD STORAGE

Model Number IUF118

Device Problem Device Alarm System (1012)

Patient Problem Insufficient Information (4580)

Event Date 11/11/2020

Event Type  malfunction  

Event Description

Helmer i.Series ultra-low temperature freezer was noted below storage recommendations for products contained within the freezer.Products such as bone grafts were moved to back-up freezer.Alarm did not function properly.Alarm stated "external probe." bone and tissue freezer operates correctly to maintain appropriate temperature settings for storage of product that may be needed for surgical procedures.

• Brand Name: I.SERIES
• Type of Device: REFRIGERATOR, FREEZER, BLOOD STORAGE
• Manufacturer (Section D): HELMER, INC.; 14400 bergen blvd; noblesville IN 46060
• MDR Report Key: 10874863
• MDR Text Key: 217328229
• Report Number: 10874863
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IUF118
• Device Catalogue Number: 5232118-1
• 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: 11/17/2020
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1