VOCERA COMMUNICATION DEVICE UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-20 for VOCERA COMMUNICATION DEVICE UNKNOWN manufactured by Vocera Communications, Inc..

Event Text Entries

[139311390] Staff on nursing unit noticed a strange smell coming from the supply room. They called plant operations to come check the supply room. When plant ops responded and entered the supply room, a puff of smoke was noticed coming from a vocera phone. Upon further inspection, the charging port and charger had melted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8435569
MDR Report Key8435569
Date Received2019-03-20
Date of Report2018-12-04
Date of Event2018-11-27
Report Date2019-03-11
Date Reported to FDA2019-03-11
Date Reported to Mfgr2019-03-20
Date Added to Maude2019-03-20
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 NameVOCERA COMMUNICATION DEVICE
Generic NameSYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITORS
Product CodeMSX
Date Received2019-03-20
Model NumberUNKNOWN
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerVOCERA COMMUNICATIONS, INC.
Manufacturer Address1950 W COOK RD STE 101 FORT WAYNE IN 46818 US 46818


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-20

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