MAUDE Adverse Event Report: JERON ELEC TRONICS, INC JERON ELECTRONICS, INC PROVIDER 790; NURSE CALL SYSTEM

Model Number	7923
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On dec.4, 2025, medwatch form was forwarded from fda to the company.Medwatch form was submitted anonymously and reported a code blue notification when the patient did not activate the call button.
Additional Manufacturer Narrative
This mdr is in response to the medwatch received dec.4, 2025 indicating a malfunction which does not meet the definition of mdr reportable event per 803.3 (o) (2) (ii).Malfunction that is a reportable event means the device has malfunctioned and that the device would be likely to cause or contribute to a death or serious injury should the malbunction recur.There is no situation where this event could cause death or serious injury.

• Brand Name: JERON ELECTRONICS, INC PROVIDER 790
• Common Device Name: NURSE CALL SYSTEM
• Manufacturer (Section D): JERON ELEC TRONICS, INC; 7501 n. natchez ave.; niles IL 60714
• Manufacturer (Section G): JERON ELECTRONICS, INC; 7501 n. natchez ave; niles IL 60714
• Manufacturer Contact: 7501 n. natchez ave,; niles, IL 60714 ; 8006211903
• MDR Report Key: 23933874
• Report Number: 3014653127-2025-00001
• Device Sequence Number: 13164597
• Product Code: ILQ
• UDI-Device Identifier: 00860002736020
• UDI-Public: (01)00860002736020
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/29/2025

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
• Operator of Device: Health Professional
• Device Model Number: 7923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 81 YR
• Patient Sex: Male