FDA Adverse Event
Injury
Summary report: N
OXYLOG 3000PLUS
MDR report key: 3010914
·
Received March 6, 2013
Report
- Report Number
- 9611500-2013-00019
- Event Type
- Injury
- Date Received
- March 6, 2013
- Date of Event
- February 19, 2013
- Report Date
- March 6, 2013
- Manufacturer
- DRAEGER MEDICAL GMBH
- Product Code
- CBK
- PMA / PMN Number
- K082600
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS ONGOING. WE WILL PROVIDE RESULTS IN A SEPARATE F/U REPORT.
Description of Event or Problem · 1
AN OXYLOG THAT WAS MOUNTED ON A BED (MODEL HILL ROM AVANTGUARD 1600). THE HOLDER BROKE DURING USE AND THE DEVICE FELL ONTO THE DOCTOR'S FOOT. NO PT INJURY REPORTED. FRACTURE OF A DOCTOR'S TOE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96525 | OXYLOG 3000PLUS | NONE | CBK | DRAEGER MEDICAL GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |