FDA Adverse Event
Malfunction
Summary report: N
POWERVAR 230V POWERSUPPLY
MDR report key: 1162329
·
Received September 8, 2008
Report
- Report Number
- 1220063-2008-00028
- Event Type
- Malfunction
- Date Received
- September 8, 2008
- Date of Event
- August 7, 2008
- Report Date
- August 8, 2008
- Manufacturer
- DRAEGER MEDICAL SYSTEMS, INC (IT/M)
- Product Code
- BSZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO THE COMPLAINANT, THE UPS HAD BEEN DISCARDED. AN INCOMPLETE SERIAL NUMBER WAS SUBMITTED AND CAN NO LONGER BE VERIFIED. THE DATE CODE GIVEN CAN BE TRANSLATED TO A PRODUCTION DATE OF THE UPS AS (B) (4) 2007. THE ROOT CAUSE FOR THE REPORTED STRONG SMOKE ODOR FROM THE UPS CANNOT BE DETERMINED AS THE CITED UPS IS NO LONGER AVAILABLE.
Description of Event or Problem · 1
CUSTOMER REPORTED STRONG SMOKE DEVELOPMENT FROM THE UPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERVAR 230V POWERSUPPLY | POWER SUPPLY | BSZ | DRAEGER MEDICAL SYSTEMS, INC (IT/M) | MS18470 | 0730057 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |