TREX HD HEADBOX-REFURB

Additional Manufacturer Narrative

INITIAL REPORT REFERENCE NATUS COMPLAINT# (B)(4). RELATED REPORT - UF/IMPORTER REPORT # 0700220000-2026-8184 RECEIVED 27 MAY 2026. PER DOC-010378 REV 87 XLTEK EEG PSG RAS HAZARD 5.17 - AMPLIFIER CHANNEL MALFUNCTIONS, SUCH AS DUE TO DAMAGE, HARDWARE FAILURE, FIRMWARE FAILURE, AGING, ETC. EFFECT (HARM): DELAYED DIAGNOSIS - WITH NO CLINICAL EFFECTS. RESIDUAL RISK: LOW THE HAZARDS IDENTIFIED HAVE RBA RATING OF NEGLIGIBLE AND ARE DEEMED BROADLY ACCEPTABLE. THESE RISKS HAVE BEEN REVIEWED TO DETERMINE IF ANY FURTHER CONTROL MEASURES MAY BE IMPLEMENTED SO AS TO FURTHER REDUCE THE RISK AS FAR AS POSSIBLE. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. NO RELATED CAPAS. INSTALL DATE OF DEVICE:18-NOV-25. REPLACEMENT PART NUMBER DESCRIPTION:TREX HD HEADBOX-REFURB SN 008043O4034 WAS SHIPPED TO THE CUSTOMER. THE AFFECTED PART WAS RETURNED. AS PER DEPOT REPAIR NOTES: REPORTED PROBLEM CONFIRMED LOOSE USB CONNECTION, DAMAGED BATTERY DOOR. REPLACED USB PORT AND BATTERY DOOR. CLEANED AND TESTED, PASSED ALL FUNCTIONAL TESTS. THE FAILURE WAS CONFIRMED. INVESTIGATION RESULT CODE: NEURO SBU/CONNECTOR DAMAGED.

Description of Event or Problem

TREX HD HEADBOX-REFURB - 24-HOUR AMBULATORY EEG [ELECTROENCEPHALOGRAM] TEST RETURNED FOR DISCONNECT AND ONLY 3 MINUTES OF DATA ABLE TO BE UPLOADED. IT WAS CONFIRMED THE BOX MALFUNCTIONED AND ONLY 3 OF THE 24 HOURS OF DATA RECORDED. BOX TAKEN OUT OF SERVICE AND BMDI [BEDSIDE MEDICAL DEVICE INTERFACE] TICKET PLACED. THIS IS THE SECOND INCIDENT IN 2 WEEKS IN WHICH AN AMBULATORY EEG PATIENT RETURNED WITH EQUIPMENT ISSUES RESULTING IS DATA NOT ACQUIRED. NO INJURIES.