M200 BED ALARM 209811

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for M200 BED ALARM 209811 manufactured by Stanley Security Solutions, Inc..

Event Text Entries

[185037009] Bed alarm did not activate.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9882710
MDR Report Key9882710
Date Received2020-03-26
Date of Report2020-03-12
Date of Event2020-03-03
Report Date2020-03-12
Date Reported to FDA2020-03-12
Date Reported to Mfgr2020-03-26
Date Added to Maude2020-03-26
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 NameM200 BED ALARM
Generic NameMONITOR, BED PATIENT
Product CodeKMI
Date Received2020-03-26
Catalog Number209811
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSTANLEY SECURITY SOLUTIONS, INC.
Manufacturer Address4600 VINE ST LINCOLN NE 68503 US 68503


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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