FDA Adverse Event
Other
Summary report: N
EAGLE
MDR report key: 301873
·
Received October 24, 2000
Report
- Report Number
- 2124823-2000-00051
- Event Type
- Other
- Date Received
- October 24, 2000
- Date of Event
- April 11, 2000
- Report Date
- September 24, 2000
- Manufacturer
- GE MARQUETTE MEDICAL SYSTEMS
- Product Code
- DPS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTS PT WAS TRANSPORTED TO POST ANESTHESIA CARE UNIT FOLLOWING SURGERY. PT WAS PUT ON THE POST SURGICAL MONITORING DEVICE BUT NURSE FAILED TO ACTIVATE ALARMS. DEVICE OPERATED AS INTENDED. INCIDENT ATTRIBUTED TO USER ERROR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EAGLE | PHYSIOLOGIC PT MONITOR | DPS | GE MARQUETTE MEDICAL SYSTEMS | EAGLE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |