QUANTUM WORKSTATION
Report
- Report Number
- 3006073153-2025-00191
- Event Type
- Malfunction
- Date Received
- August 6, 2025
- Date of Event
- July 18, 2025
- Report Date
- September 24, 2025
- Manufacturer
- SPECTRUM MEDICAL LTD
- Product Code
- DRY
- PMA / PMN Number
- K163657
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CONCLUSION AWAITING RETURN OF DEVICE.
SYSTEM LOGS WERE REVIEWED, AND THE QWS TRIGGERED SOME COMMUNICATION ALERTS. HOWEVER, AT NO TIME DID ANY MODULE STOP OR LOSE POWER. SUSPECT QWS SAP CABLE LOOSE / OR NOT FULLY INSERTED.
USER REPORTED THAT WHILE ON BYPASS THERE WAS AN ERROR THAT WOULD APPEAR OCCASIONALLY FOR A FEW SECONDS. ERROR DISPLAYED WAS A "CHECK CABLE CONNECTION" ERROR, WHEN THIS ERROR OCCURRED THE PUMP WOULD STOP. USER REPORTED THAT THE CABLE FOR THE PUMP WAS "VERY SLIGHTLY NOT SEATED IN, BUT AFTER PUSHING IT IN FURTHER THE ISSUE PERSISTED ANYWAY". THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.
USER REPORTED THAT WHILE ON BYPASS THERE WAS AN ERROR THAT WOULD APPEAR OCCASIONALLY FOR A FEW SECONDS. ERROR DISPLAYED WAS A "CHECK CABLE CONNECTION" ERROR, WHEN THIS ERROR OCCURRED THE PUMP WOULD STOP. USER REPORTED THAT THE CABLE FOR THE PUMP WAS "VERY SLIGHTLY NOT SEATED IN, BUT AFTER PUSHING IT IN FURTHER THE ISSUE PERSISTED ANYWAY". THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1725993 | QUANTUM WORKSTATION | BLOOD GAS MONITOR | DRY | SPECTRUM MEDICAL LTD | QWS 12" HR STD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |