FDA Adverse Event
Other
Summary report: N
PRIMUS
MDR report key: 2110088
·
Received May 23, 2011
Report
- Report Number
- 9611500-2011-00015
- Event Type
- Other
- Date Received
- May 23, 2011
- Date of Event
- April 7, 2011
- Report Date
- May 13, 2011
- Manufacturer
- DRAGER MEDICAL GMBH
- Product Code
- BSZ
- PMA / PMN Number
- K042607
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS ONGOING. THE RESULTS OF THE INVESTIGATION WILL BE PART OF A FOLLOW-UP.
Description of Event or Problem · 1
IT WAS REPORTED: "STOP OF RESPIRATOR DURING USE. NO AUDIBLE ALARM, ONLY A VISUAL ALARM: RED CROSS ON THE LOWER LEFT CORNER OF THE RESPIRATOR + MESSAGE "VENTILATOR FAILURE". IN ADDITION IT WAS REPORTED THAT THE PATIENT HAS DESATURATED (B)(6) AND THAT AN INCREASE OF THE DURATION OF THE INTERVENTION OF MORE THAN 30 MINUTES OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIMUS | ANESTHESIA WORKSTATION | BSZ | DRAGER MEDICAL GMBH | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Required Intervention |