MAUDE Adverse Event Report: RENU MEDICAL, INC STANLEY HEALTHCARE BED-CHECK ST CHAIR SENSORMAT; MONITOR, BED PATIENT

Model Number	RM-73030
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Sensormat was in place under patient and electrical interference noted on telemetry monitor.Manufacturer response for monitor, bed patient, stanley healthcare (per site reporter).Unknown.

• Brand Name: STANLEY HEALTHCARE BED-CHECK ST CHAIR SENSORMAT
• Common Device Name: MONITOR, BED PATIENT
• Manufacturer (Section D): RENU MEDICAL, INC; 5900 36th ave w; ste 100; everett WA 98203
• MDR Report Key: 20891706
• Report Number: 20891706
• Device Sequence Number: 9043622
• Product Code: KMI
• UDI-Device Identifier: 00816317024024
• UDI-Public: (01)00816317024024
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/03/2024
• Report Date (Section F): 12/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RM-73030
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 12/03/2024