FDA Adverse Event
Other
Summary report: N
DATEX-OHMEDA S/5 LIGHT MONITOR
MDR report key: 513557
·
Received January 20, 2004
Report
- Report Number
- 9610105-2004-00001
- Event Type
- Other
- Date Received
- January 20, 2004
- Date of Event
- December 15, 2003
- Report Date
- January 15, 2004
- Manufacturer
- INSTRUMENTARIUM CORP., DATEX-OHMEDA DIVISION
- Product Code
- MHX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE LIGHT MONITORS ARE NETWORKED TO A CENTRAL C-NET99. IT HAS BEEN REPORTED OVER A NUMBER OF MONTHS THAT ON OCCASION, THE CENTRAL DOES NOT ALARM WHEN ANY PT LEADS ARE REMOVED. THE LIGHT MONITORS ARE CONNECTED TO THE PT USING 3 LED DATEX ECG CABLES. A WHITE TECHNICAL ALARM IS ALWAYS SEEN ON THE MONITOR, BUT A PRIORITY YELLOW ALARM IS NOT SENT TO THE CENTRAL. THE PROBLEM OCCURS SPORADICALLY ON 5 DIFFERENT UNITS. ALL ECG BDS HAVE BEEN REPLACED. FAULT STILL OCCURS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DATEX-OHMEDA S/5 LIGHT MONITOR | DATEX-OHMEDA S/5 MULTIPARAMETER PT MONITOR | MHX | INSTRUMENTARIUM CORP., DATEX-OHMEDA DIVISION | F-LMP1...00 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |