FDA.reportPublic FDA data

MAUDE MDR 3973010

MDR report key
3973010
Report number
MW5037537
Event key
0
Event type
3
Date of event
2014-07-21
Date received
2014-07-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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
1JERONCALL SYSTEMJERON ELECTRONICS SYSTEMSILQ680

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-07-2901. H

Event Narratives#

D

Patient 1

CODE BUTTON HAD MALFUNCTION WHEN PUSHED BY A PATIENT - REPAIRS HAD BEEN MADE THE DAY PRIOR. MALFUNCTIONED WITH ACTUAL CODE SITUATION ON (B)(6) 2014. CODE CALLED OVERHEAD VIA PHONE SYSTEM. COMPANY CALLED FOR REPAIR. REPAIRS HAD BEEN MADE PREVIOUSLY DUE TO AN INCIDENT WHERE THE CALL LIGHT BUTTON WAS NOT AUDIBLE AND FOUND TO BE AN ISSUE WITH THE INSTALLATION OF THE CALL SYSTEM BY THE VENDOR.