FDA Adverse Event
Other
Summary report: N
DATEX-OHMEDA CARDIOCAP II
MDR report key: 273734
·
Received April 12, 2000
Report
- Report Number
- 9610105-2000-00001
- Event Type
- Other
- Date Received
- April 12, 2000
- Date of Event
- March 7, 2000
- Report Date
- April 11, 2000
- Manufacturer
- INSTRUMENTARIUM CORP./DATEX-OHMEDA DIVISION
- Product Code
- DRT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING AN ENDOSCOPIC PROCEDURE ("C.R.P", BILIAR BLADDER) THE PT WITH DEEP SEDATION SUFFERED APNEA SITUATION FOR A TIME PERIOD THAT IS NOT KNOWN AT THE MOMENT. CAUSE FOR APNEA SITUATION IS UNKNOWN AS WELL. THE SATURATION PULSE OXIMETER READING DISPLAYED ON THE MONITOR WAS REPORTED TO BE 100% AT THE TIME OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DATEX-OHMEDA CARDIOCAP II | HEMODYNAMIC PATIENT MONITOR | DRT | INSTRUMENTARIUM CORP./DATEX-OHMEDA DIVISION | CH-S | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Hospitalization |