MAUDE Adverse Event Report: STANLEY HEALTHCARE SENSORMAT; 14-DAY BEDCHECK PAD

Model Number MTZ74030

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/09/2016

Event Type  malfunction  

Event Description

Patient was observed walking around to the other side of the bed and sitting back down.After sitting back down, the chair pad alarmed.

• Brand Name: SENSORMAT
• Type of Device: 14-DAY BEDCHECK PAD
• Manufacturer (Section D): STANLEY HEALTHCARE; 130 turner street; building #3; waltham MA 02453
• MDR Report Key: 6310342
• MDR Text Key: 66781825
• Report Number: 6310342
• 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: 12/30/2016,01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MTZ74030
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 93