FDA Adverse Event
Malfunction
Summary report: N
DELTA XL
MDR report key: 2110458
·
Received April 25, 2011
Report
- Report Number
- 1220063-2011-00016
- Event Type
- Malfunction
- Date Received
- April 25, 2011
- Date of Event
- March 29, 2011
- Report Date
- March 24, 2011
- Manufacturer
- DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
- Product Code
- DSI
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DRAEGER IS STILL INVESTIGATING THE REPORTED INCIDENT. A F/U REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT BLACKOUT OF SPO2 MEASUREMENT OCCURRED UNEXPECTEDLY. CURVE AND READINGS WERE NOT DISPLAYED. THERE WAS NO PT INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTA XL | PATIENT MONITOR | DSI | DRAEGER MEDICAL SYSTEMS, INC. (IT/M) | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | NO |