FDA Adverse Event
Malfunction
Summary report: N
INFINITY CENTRAL STATION
MDR report key: 964974
·
Received December 14, 2007
Report
- Report Number
- 1220063-2007-00042
- Event Type
- Malfunction
- Date Received
- December 14, 2007
- Date of Event
- November 14, 2007
- Report Date
- December 10, 2007
- Manufacturer
- DRAEGER MEDICAL SYSTEMS, INC.
- Product Code
- MHX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT IS CURRENTLY UNDER INVESTIGATION.
Description of Event or Problem · 1
DRAEGER MEDICAL SYSTEMS, INC. HAS RECEIVED INFORMATION FROM A CUSTOMER THAT OUR INFINITY CENTRAL STATION DISPLAY, INCLUDING WAVEFORMS ON THE MAIN SCREEN BECAME FROZEN AND REMAINED FROZEN FOR AN UNK LENGTH OF TIME. THE HOSPITAL BIOMED TRIED TO TELNET INTO THE DEVICE, BUT WAS UNSUCCESSFUL, A MANUAL RESET WAS PERFORMED ON THE INFINITY CENTRAL STATION USING THE POWER SWITCH ON THE FRONT OF THE UNIT. AFTER REBOOTING, THE INFINITY CENTRAL STATION FUNCTIONED NORMALLY. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINITY CENTRAL STATION | CENTRAL STATION PATIENT MONITORING SYSTEM | MHX | DRAEGER MEDICAL SYSTEMS, INC. | MS18267 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI YR |