MEDICAL GRADE UPS WITH ISOLATION - 110V ERGOJUST CART
Report
- Report Number
- 9612330-2025-00021
- Event Type
- Malfunction
- Date Received
- October 20, 2025
- Date of Event
- October 14, 2025
- Report Date
- March 23, 2026
- Manufacturer
- NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD.
- Product Code
- GWQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
FOLLOW UP REPORT 001 REFERENCE NATUS COMPLAINT# (B)(4). THIS DEVICE WAS RETURNED AND ANALYZED BY NATUS ENGINEERING AND THEN SENT TO THE MANUFACTURER FOR FURTHER EVALUATION. NATUS ENGINEERING OPENED AND EVALUATED THE DEVICE BY VISUAL INSPECTION AND CONCLUDED A MOSFET FAILURE. THEY STATED THE DEVICE IS IEC 60601-1, UL 94V-0 COMPLIANT AND WILL SELF-EXTINGUISH PER THE UL 94V-0 REQUIREMENTS, UPON FAILURE THE DEVICE WILL NO LONGER BE FUNCTIONAL. (B)(6) 2026: THE DEVICE WAS EVALUATED BY THE MANUFACTURER POWERVAR. INVESTIGATION RESULTS: AFTER VERIFICATION OF THE UPS MENTIONED, THEY FOUND SIGNIFICANT DAMAGES ON THE MAIN BOARD DUE TO MOSFET (METAL OXIDE SEMICONDUCTOR FIELD EFFECT TRANSISTOR) FAILURE. THE FOLLOWING COMPONENTS WERE FOUND FAULTY: 1. FUSE F1, F2, F3: 20A (CAR BATTERY FUSES), 2. FUSE F4: 5A / 250V, 3. GATE DRIVE RESISTORS, 4. DAMAGED TRACKS, 5. 8 X MOSFET WITH REFERENCE (B)(4).
FOLLOW UP REPORT 002 REFERENCE NATUS COMPLAINT# (B)(4) ADDITIONAL INFORMATION REQUEST FOR MDR 9612330-2025-00021 WAS SENT FEB 25, 2026 IN RELATION TO THE FOLLOWING QUESTIONS: 1. HOW YOU DETERMINED THAT THIS ISSUE IS SPECIFIC TO THE SINGLE DEVICE AND HOW YOU CONFIRMED THAT THIS ISSUE DOES NOT IMPACT ANY OTHER DEVICES. THESE DEVICES ARE NOT MADE IN BATCHES; THEY ARE MANUFACTURED AND TESTED ONE AT A TIME. THIS IS THE FIRST TIME WE HAVE SEEN THIS TYPE OF FAILURE WITH A MANUFACTURE STATING THE CAUSE OF OVERLOAD. 2. WHY THE FAILURE OCCURRED AND WHAT FACTORS CONTRIBUTED TO THE FAILURE. POWERVAR'S INVESTIGATION RESULTS STATED THE FOLLOWING: THE UNIT HAS A BLOWN PCB. IT IS BELIEVED TO BE A POSSIBLE OVERLOADED UPS CAUSING THE FETS TO BLOW. NATUS HAS ANALYZED THE SYSTEM RATED LOAD TO BE 3.1 AMPS. WE ARE WITHIN 68% RATED MAX OF THE UPS WHICH IS 4.5 AMPS, MEANING WE HAVE SUFFICIENT OVERHEAD AND THIS IS A SPECIFIC, INDIVIDUAL DEVICE FAILURE.
INITIAL REPORT REFERENCE NATUS COMPLAINT#: (B)(4). PER (B)(4) REV 86 XLTEK EEG/PSG RISK ANALYSIS SPREADSHEET. HAZARD 2.1 - FAILURE OF AMPLIFIER POWER SUPPLY/ TRANSFORMER. EFFECTS (HARM) - FIRE - SMOKE INHALATION, SECOND DEGREE BURNS, THIRD DEGREE BURNS. RESIDUAL RISK - 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. TECHNICAL SERVICE SENT THE CUSTOMER A QUESTIONNAIRE AND REQUESTED THEY RETURN THE ALLEGEDLY DEFECTIVE UNIT FOR INVESTIGATION.
UPS ((B)(6) ABCE602-11MED PN: UPS-NA-EJ) UNIT ON PORTABLE CART BURNED UP OVER THE WEEKEND, REPORT OF SPARKS AND SMOKE, SIDE OF CASING IS BURNED. NO INJURIES REPORTED.
UPS (B)(4) UNIT ON PORTABLE CART BURNED UP OVER THE WEEKEND, REPORT OF SPARKS AND SMOKE, SIDE OF CASING IS BURNED. NO INJURIES REPORTED.
UPS (B)(4) PN: UPS-NA-EJ) UNIT ON PORTABLE CART BURNED UP OVER THE WEEKEND, REPORT OF SPARKS AND SMOKE, SIDE OF CASING IS BURNED. NO INJURIES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2860223 | MEDICAL GRADE UPS WITH ISOLATION - 110V ERGOJUST CART | MEDICAL GRADE UPS WITH ISOLATION - 110V ERGOJUST CART | GWQ | NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. | UPS-NA-EJ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |