MalfunctionKSE
I.SERIES
Received Nov 20, 2020 · Event occurred Nov 11, 2020
Report 10874863 · MDR key 10874863
Device
Generic name
Refrigerator, Freezer, Blood Storage
Manufacturer
Helmer, Inc.Model number
IUF118Catalog number
5232118-1
Product problems
- Device Alarm System
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
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.