FDA Adverse Event
Other
Summary report: N
ACCUTRON
MDR report key: 3139945
·
Received May 29, 2013
Report
- Report Number
- 1044295-2013-00001
- Event Type
- Other
- Date Received
- May 29, 2013
- Date of Event
- April 29, 2013
- Report Date
- May 29, 2013
- Manufacturer
- THE HARRIS PRODUCTS GROUP
- Product Code
- CAN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
(REFERENCE VOLUNTARY REPORT # (B)(4)) THE TECHNICIAN WERE REPORTED AS TURNING ON THE GAS CYLINDER (PRESUMABLY OPENING THE VALVE ON THE CYLINDER) WHEN A FIRE OCCURRED. THE OXYGEN REGULATOR, AS SHOWN IN PHOTOS PROVIDED BY THE REPORTER, APPEARS TO HAVE BEEN DAMAGE IN THE FIRE. THE SEQUENCE OF EVENTS RESULTING IN THE FIRE ARE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 233769 | ACCUTRON | OXYGEN PRESSURE REGULATOR | CAN | THE HARRIS PRODUCTS GROUP | 25-2T559-540 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Other |