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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANLEY SECURITY SOLUTIONS, INC. BED-CHECK; BED PATIENT MONITOR
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STANLEY SECURITY SOLUTIONS, INC. BED-CHECK; BED PATIENT MONITOR Back to Search Results
Model Number 74030
Device Problem Defective Alarm (1014)
Patient Problem Fall (1848)
Event Date 10/13/2016
Event Type  malfunction  
Manufacturer Narrative
Device was not quarantined by user facility for return and evaluation.Device not kept for return by facility.
 
Event Description
Patient was found lying on the floor.Bed alarm was plugged into the wall and unit was not alarming, upon inspection the alarm was no longer sounding appropriately.
 
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Brand Name
BED-CHECK
Type of Device
BED PATIENT MONITOR
Manufacturer (Section D)
STANLEY SECURITY SOLUTIONS, INC.
4600 vine street
lincoln NE 68503
Manufacturer (Section G)
STANLEY SECURITY SOLUTIONS, INC.
4600 vine street
lincoln NE 68503
Manufacturer Contact
gina bennett
4600 vine street
lincoln, NE 68503
4027429322
MDR Report Key6413106
MDR Text Key70336819
Report Number1929691-2017-00009
Device Sequence Number1
Product Code KMI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number74030
Device Catalogue Number74030
Device Lot NumberN/I
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/30/2016
Date Manufacturer Received02/20/2017
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age54 YR
Patient Weight49
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