FDA Adverse Event
Injury
Summary report: N
4 WAVE MONITOR
MDR report key: 479294
·
Received August 22, 2003
Report
- Report Number
- 1218950-2003-00157
- Event Type
- Injury
- Date Received
- August 22, 2003
- Date of Event
- July 22, 2003
- Report Date
- July 22, 2003
- Manufacturer
- AGILENT TECHNOLOGIES, INC.
- Product Code
- DRT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE PT HAD A SATURATION LEVEL OF LESS THAN 50 AND THE MONITOR WAS NOT ALARMING. THE ALARM LIMITS WERE SET AT 80 AND 100. THE USER ALLEGED THAT THE ALARMS WERE NOT SUSPENDED. THERAPY WAS ADMINISTERED TO THE PT TO BRING THE SATURATION LEVEL UP TO GREATER THAN 80. THE USER STATED THAT THERE WAS NO ADVERSE IMPACT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4 WAVE MONITOR | * | DRT | AGILENT TECHNOLOGIES, INC. | M1204A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 MO | Life Threatening| R |