ASCOM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-22 for ASCOM manufactured by Ascom Us, Inc..

Event Text Entries

[175912536] Ascom phone battery combusted in the smock of resident while rounding. No injuries noted. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092386
MDR Report Key9617349
Date Received2020-01-22
Date of Report2020-01-17
Date of Event2019-12-19
Date Added to Maude2020-01-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameASCOM
Generic NameSYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITORS
Product CodeMSX
Date Received2020-01-22
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerASCOM US, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-22

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