MAUDE Adverse Event Report: TIDI PRODUCTS LLC CHAIR ALARM BELT; MONITOR, BED PATIENT

Model Number	8399
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: CHAIR ALARM BELT
• Common Device Name: MONITOR, BED PATIENT
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 25862041
• Report Number: 2182318-2026-00070
• Device Sequence Number: 17532467
• Product Code: KMI
• UDI-Device Identifier: 10190676006202
• UDI-Public: 10190676006202
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

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: 8399
• Device Catalogue Number: 8399
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 07/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White