MAUDE Adverse Event Report: STANLEY SECURITY SOLUTIONS, INC. BED CHECK; MONITOR, BED PATIENT

Model Number 72100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

Information provided by user facility does not indicate a product problem.Report indicates a red light was showing after the event, which is the visual indication of a fall alarm being properly generated.Report that the light turned green again after the fall indicates either that weight was placed back on the pad, or that the alarm condition was reset.It is possible that the alarm did not sound audibly due to user settings on the monitor, which allows local silence if a nurse call system is connected to the monitor.In situ observation was performed, including audits of monitor usage at the facility.Behavior as described was not reproduced during in situ observation.Facility did not quarantine for return.

Event Description

From user facility medwatch report: "bed check did not alarm and patient fell.No patient harm.Solid green light showing on unit prior to fall.Transmitter hooked up correctly.Bed check pad in good condition, no bends.Red light showing after fall, but then turned green again.".

• Brand Name: BED CHECK
• Type of Device: MONITOR, BED PATIENT
• 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 Key: 6357394
• MDR Text Key: 68362602
• Report Number: 1929691-2017-00006
• Device Sequence Number: 1
• Product Code: KMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 72100
• Device Catalogue Number: 72100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/27/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR