FDA.reportPublic FDA data

MAUDE MDR 4146566

MDR report key
4146566
Report number
4146566
Event key
0
Event type
3
Date of event
2014-09-16
Date received
2014-09-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1REVCO ULTIMA SERIESFREEZERTHERMO FISHER SCIENTIFIC (ASHEVILLE), LLCJRM*** Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-09-290

Event Narratives#

D

Patient 1

BONE FREEZER NOT MAINTAINING PROPER TEMPERATURE. SERVICE COMPANY CAME OUT TO EVALUATE PROBLEM, GAVE HIGH DOLLAR ESTIMATE TO REBUILD COMPRESSORS IN FREEZER. BIOMED CONTACTED MANUFACTURER WHO IS GOING TO REBUILD THE COMPRESSORS AT A MUCH LOWER COST. THIS UNIT IS 6.5 YRS OLD AND THIS HAS BEEN AN ONGOING PROBLEM AS WELL AS WITH OTHER ISSUES. SERVICE COMPANY COMES OUT TO EVALUATE ISSUES WITH HISTORY OF REPLACING PARTS WITH NO DEFINITIVE PROBLEM IDENTIFIED OR SOLVED.