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

Model Number 73050

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

No consequence to patient, as this failure was reported from testing of the system before use.Based on report, user followed instructions and tested system before use and removed component which failed testing.As pad was not returned, further evaluation in to cause of test failure is not possible.Facility did not quarantine pad to return.

Event Description

From user facility medwatch form: "bed check pad would not connect to the device.Another pad was obtained and connected without difficulty.".

• 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: 6357365
• MDR Text Key: 68368886
• Report Number: 1929691-2017-00005
• 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: 73050
• Device Catalogue Number: 73050
• Device Lot Number: A0516
• 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: 05/01/2016
• 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: 90 YR