FDA.reportPublic FDA data

MAUDE MDR 4387175

MDR report key
4387175
Report number
MW5039954
Event key
0
Event type
3
Date of event
2014-10-13
Date received
2014-12-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PHILIPS INTEGRIS HXRAY SYSTEMPHILIPSIZFERROR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-12-300

Event Narratives#

D

Patient 1

FILMS FROM BIVENTRICULAR PERMANENT PACEMAKER PLACEMENT AND ABLATION UNABLE TO BE SENT TO PERMANENT STORAGE. PHILIPS SERVICE REP EVALUATED EQUIPMENT AND FELT REASON FILMS WOULD NOT BE SENT WAS DUE TO THE CASE FILE BEING CORRUPT. FILMS HAD TO BE DELETED FROM EQUIPMENT. CATH LAB 7.