FDA Adverse Event
Injury
Summary report: N
DRAGER
MDR report key: 770336
·
Received October 16, 2006
Report
- Report Number
- MW1040697
- Event Type
- Injury
- Date Received
- October 16, 2006
- Date of Event
- July 27, 2006
- Report Date
- October 16, 2006
- Manufacturer
- DRE INC
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DRAGER VENT. SCREEN WENT BLANK AND THE VENTILATOR STARTED TO MAKE A LOUD HIGH PITCHED NOISE. THE STAFF TURNED THE VENT. OFF. PT BAGGED AND RESPIRATORY STATUS WAS MAINTAINED WITH O2 SATS AT 100%. THE PT SUFFERED NO ILL EFFECTS FROM THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRAGER | VENTILATOR | CBK | DRE INC | EVITA XL 16 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Disability |