QUANTUM WORKSTATION
Report
- Report Number
- 3006073153-2025-00284
- Event Type
- Malfunction
- Date Received
- November 20, 2025
- Date of Event
- October 21, 2025
- Report Date
- January 19, 2026
- Manufacturer
- SPECTRUM MEDICAL LTD.
- Product Code
- DRY
- UDI-DI
- 05060434420008
- PMA / PMN Number
- K163657
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DEVICE INVESTIGATION TO BE COMPLETED ON RETURN OF DEVICE. FINAL REPORT (B)(6) 2026: HOSPITAL SENSOR FOUND TO HAVE FRACTURED FIBRE OPTIC CABLE - ACCIDENTAL DAMAGE. QUANTUM WORKSTATION WAS UNABLE TO RECOGNISE THE SENSOR IN THIS CASE, HOWEVER FOLLOWING TESTING ON RETURN TO HQ, QUANTUM WORKSTATION FUNCTIONED AS EXPECTED - NO FAULT FOUND. SUBJECT DEVICE PREVENTATIVE MAINTENANCE COMPLETED, SENSOR REPLACED. SENSOR DAMAGE IS NOT A REPORTABLE EVENT AS PER COMPANY CRITERIA.
DEVICE INVESTIGATION TO BE COMPLETED ON RETURN OF DEVICE.
USER REPORTED THE DEVICE WAS DISPLAYING "!!!" FOR MULTIPLE VALUES. HCT/SAT SENSOR WIPED CLEAN AND VALUES FACTORY RESET, SENSOR REPLACED, HARD REBOOTS PERFORMED AND THE VALUES WERE STILL ALARMING. QWS SWAPPED TO ANOTHER HLM AND IT WORKED FOR A CASE, WITH ERRORS REAPPEARING THE NEXT DAY.
USER REPORTED THE DEVICE WAS DISPLAYING "!!!" FOR MULTIPLE VALUES. HCT/SAT SENSOR WIPED CLEAN AND VALUES FACTORY RESET, SENSOR REPLACED, HARD REBOOTS PERFORMED AND THE VALUES WERE STILL ALARMING. QWS SWAPPED TO ANOTHER HLM AND IT WORKED FOR A CASE, WITH ERRORS REAPPEARING THE NEXT DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176411 | QUANTUM WORKSTATION | EXTRACORPOREAL BLOOD GAS/PH MONITOR | DRY | SPECTRUM MEDICAL LTD. | QWS | 05060434420008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |