MAUDE MDR 7548987

MDR report key
7548987
Report number
MW5077469
Event key
0
Event type
3
Date of event
2018-05-14
Date received
2018-05-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RADIOLOGY XR7 FILM READER/ FILM RADIOGRAPHICRADIOLOGY XR7 FILM READER/ FILM RADIOGRAPHICKONICA MINOLTA, INC.IWZCS-3I N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-250

Event Narratives#

D

Patient 1

KONICA READER SHUT DOWN DUE TO HARD DRIVE FAILURE. RADIOLOGY IMAGES LOST. PATIENT NEEDED IMAGES RETAKEN.