MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; MONITOR, BED PATIENT

Model Number M2200-CP-CS2

Device Problem Failure to Sense (1559)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2021

Event Type  malfunction  

Event Description

Chair sensor pad for chair alarm for fall precautions are noted to fail when the patient stands and the alarm does not go of.Chair sensor pad and connectivity point to the portable chair alarm box appropriately engaged, batteries ok.Testing with a new chair pad to the chair alarm box works well.Additionally, if chair sensor pad gets wet from incontinence through incontinence pads on the chair (over the chair sensor pad), the chair sensor will also not work.

• Brand Name: DEROYAL
• Type of Device: MONITOR, BED PATIENT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 12819437
• MDR Text Key: 280834050
• Report Number: 12819437
• Device Sequence Number: 1
• Product Code: KMI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M2200-CP-CS2
• Device Catalogue Number: M2200-CP-CS2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1