EMU40EX BREAKOUT BOX-REFURB
Report
- Report Number
- 9612330-2025-00019
- Event Type
- Malfunction
- Date Received
- September 2, 2025
- Date of Event
- August 22, 2025
- Report Date
- December 11, 2025
- Manufacturer
- NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD.
- Product Code
- GWQ
- UDI-DI
- 00382830011297
- PMA / PMN Number
- K163163
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
FOLLOW UP REPORT 001 REFERENCE NATUS COMPLAINT# (B)(4). ON 24 SEPT 2025 - THE AFFECTED DEVICE WAS RECEIVED BY NATUS IRELAND, AND WILL BE SHIPPED TO THE MIDDLETON SITE FOR EVALUATION.
FOLLOW UP REPORT 002 REFERENCE NATUS COMPLAINT# (B)(4). 10-OCT-2025 DEVICE RECEIVED IN MIDDLETON AND DELIVERED TO ENGINEERING FOR EVALUATION. 20-OCT-2025 QA FOLLOWED UP WITH ENGINEERING. INVESTIGATION RESULTS NOT YET AVAILABLE.
FOLLOW UP REPORT 003 REFERENCE NATUS COMPLAINT#: (B)(4). PER DOC-010378 REV 86 XLTEK EEG / PSG RISK ANALYSIS SPREADSHEET (RAS). HAZARD 2.9 - INTERNAL SHORT CIRCUIT. EFFTECT (HARM) - FIRE - SMOKE INHALATION, SECOND DEGREE BURNS, THIRD DEGREE BURNS. SEVERITY - MEDIUM. THE HAZARDS IDENTIFIED HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH A KNOWN STANDARD. AS NOTED IN QMS-000018, HAZARDS THAT HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH KNOWN STANDARDS CAN BE PRESUMED TO BE CONSISTENT WITH AN ACCEPTABLE LEVEL OF RISK, YIELDING AN ACCEPTABLE RISK / BENEFIT TO THE PATIENT OR USER. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. NO RELATED CAPAS. INVESTIGATION RESULTS: THE DEVICE WAS OPENED AND EVALUATED TO SEE IF THERE WAS ANY SIGN OF FAILED OR BURNT COMPONENTS. THERE WERE NO FAILED OR BURNT COMPONENTS OBSERVED. FUNCTIONAL TESTING WAS CONDUCTED ON THE DEVICE WITH NO FAILURES OBSERVED. ROOT CAUSE/PROBABLE ROOT CAUSE: N/A, NO FAILURES OBSERVED. RECOMMENDED ACTIONS: DEVICE IS AGED AND WILL BE SCRAPPED. NO FURTHER ACTIONS.
INITIAL REPORT REFERENCE NATUS COMPLAINT#: (B)(4). PER (B)(4) REV 86 XLTEK EEG / PSG RISK ANALYSIS SPREADSHEET (RAS). HAZARD 2.9 - INTERNAL SHORT CIRCUIT. EFFTECT (HARM) - FIRE - SMOKE INHALATION, SECOND DEGREE BURNS, THIRD DEGREE BURNS. SEVERITY - MEDIUM. THE HAZARDS IDENTIFIED HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH A KNOWN STANDARD. AS NOTED IN QMS-000018, HAZARDS THAT HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH KNOWN STANDARDS CAN BE PRESUMED TO BE CONSISTENT WITH AN ACCEPTABLE LEVEL OF RISK, YIELDING AN ACCEPTABLE RISK / BENEFIT TO THE PATIENT OR USER. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. INSTALL DATE: ON (B)(6) 2024.
PART 006562R, EMU40EX BREAKOUT BOX-REFURB - SMOKE WAS EMITTED FROM TWO BASE UNITS IN CONNECTION WITH THIS BREAKOUT BOX. NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS VIDEO-EEG. THE SMOKE AND ODOR APPEARED IMMEDIATELY AFTER STARTING THE REGISTRATION.
PART 006562R, EMU40EX BREAKOUT BOX-REFURB - SMOKE WAS EMITTED FROM TWO BASE UNITS IN CONNECTION WITH THIS BREAKOUT BOX. NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS VIDEO-EEG. THE SMOKE AND ODOR APPEARED IMMEDIATELY AFTER STARTING THE REGISTRATION.
PART: 006562R, EMU40EX BREAKOUT BOX-REFURB - SMOKE WAS EMITTED FROM TWO BASE UNITS IN CONNECTION WITH THIS BREAKOUT BOX. NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS VIDEO-EEG. THE SMOKE AND ODOR APPEARED IMMEDIATELY AFTER STARTING THE REGISTRATION.
PART: 006562R, EMU40EX BREAKOUT BOX-REFURB - SMOKE WAS EMITTED FROM TWO BASE UNITS IN CONNECTION WITH THIS BREAKOUT BOX. NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS VIDEO-EEG. THE SMOKE AND ODOR APPEARED IMMEDIATELY AFTER STARTING THE REGISTRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2864876 | EMU40EX BREAKOUT BOX-REFURB | EMU40EX BREAKOUT BOX-REFURB | GWQ | NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. | 006562R | 00382830011297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |