MAUDE Adverse Event Report: SECA SECA 284; SCALE, STAND-ON, PATIENT

Model Number	284
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient stepped on emergency department triage scale with force and glass weighing surface shattered/exploded.

• Brand Name: SECA 284
• Common Device Name: SCALE, STAND-ON, PATIENT
• Manufacturer (Section D): SECA; 13601 benson ave; chino CA 91710
• MDR Report Key: 19163192
• Report Number: 19163192
• Device Sequence Number: 7948916
• Product Code: FRI
• UDI-Device Identifier: 04012030020435
• UDI-Public: (01)04012030020435
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2024
• Report Date (Section F): 04/09/2024

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: 284
• Device Catalogue Number: 2841000109
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/09/2024