TELLIGENCE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-05 for TELLIGENCE manufactured by Ascom (us) Inc..

Event Text Entries

[122798766] Call bell system failed in unit.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7937726
MDR Report Key7937726
Date Received2018-10-05
Date of Report2018-09-28
Date of Event2018-07-05
Report Date2018-09-28
Date Reported to FDA2018-09-28
Date Reported to Mfgr2018-10-05
Date Added to Maude2018-10-05
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTELLIGENCE
Generic NameSYSTEM, ENVIRONMENTAL CONTROL, POWERED
Product CodeIQA
Date Received2018-10-05
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerASCOM (US) INC.
Manufacturer Address9024 TOWN CENTER PARKWAY BRADENTON FL 34202 US 34202


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-05

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