FDA Adverse Event
Malfunction
Summary report: N
SPACELABS ARKON ANESTHESIA WORKSTATION
MDR report key: 3182934
·
Received June 21, 2013
Report
- Report Number
- 3023361-2013-00043
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- June 3, 2013
- Report Date
- June 21, 2013
- Manufacturer
- SPACELABS MEDICAL INC.
- Product Code
- CBK
- PMA / PMN Number
- K113051
- Removal / Correction Number
- 9611295-06/20/13-002-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO ONE WAS INJURED AS A RESULT OF THIS EVENT. SPACELABS HAS INVESTIGATED THIS REPORTED EVENT AND HAS DETERMINED THAT THE ARKON ANESTHESIA WORKSTATIONS HAVE A SOFTWARE ERROR RELATED TO THE SYSTEM STATUS COMPUTER. THE COMPUTER INCORRECTLY PERCEIVES AN ISSUE WITH INTERNAL OPERATION, THEN NOTIFIES THE USER OF THE PERCEIVED ISSUES. SPACELABS HAS INITIATED A FIELD CORRECTIVE ACTION FOR THE ARKON ANESTHESIA WORKSTATIONS, AND WILL PROVIDE A SOFTWARE REVISION CURING THE ERROR.
Description of Event or Problem · 1
SPACELABS RECEIVED A REPORT THAT THE ARKON ANESTHESIA WORKSTATION STARTED GIVING A HIGH PITCHED BUZZ AND THE DISPLAY ON THE SYSTEM STATUS COMPUTER WENT BLACK EXCEPT FOR A YELLOW TRIANGLE IN THE MIDDLE OF THE SCREEN (WHICH IS THE CAUTION SYMBOL WARNING PICTOGRAM).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 284151 | SPACELABS ARKON ANESTHESIA WORKSTATION | ANESTHESIA WORKSTATION WITH CONTINUOUS VENTILATOR | CBK | SPACELABS MEDICAL INC. | 99999 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ARKON ((B)(4)) ARKON ((B)(4)) |