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

Model Number 73030

Device Problem Defective Alarm (1014)

Patient Problem Fall (1848)

Event Date 09/27/2016

Event Type  malfunction  

Event Description

Patient was sitting in the chair with chair alarm pad on and plugged in to receptacle with "bed alarm." the patient stood up and fell, the alarm did not alert.No patient injury.A nurse sat on the chair pad several times before it alarmed.

• Brand Name: STANLEY HEALTHCARE BED-CHECK SENSORMAT
• Type of Device: MONITOR, BED PATIENT
• Manufacturer (Section D): STANLEY SECURITY SOLUTIONS, INC.; 4600 vine street; lincoln NE 68503
• MDR Report Key: 6144606
• MDR Text Key: 61428534
• Report Number: 6144606
• Device Sequence Number: 1
• Product Code: KMI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 73030
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/23/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 65