FDA Adverse Event
Malfunction
Summary report: N
BSM-1733A
MDR report key: 4949394
·
Received July 27, 2015
Report
- Report Number
- 2080783-2015-00186
- Event Type
- Malfunction
- Date Received
- July 27, 2015
- Date of Event
- July 1, 2015
- Report Date
- July 1, 2015
- Manufacturer
- NIHON KOHDEN CORP.
- Product Code
- MHX
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE BEDSIDE VITAL SIGN MONITOR HAS A BURNING SMELL COMING FROM THE CHARGING UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 485744 | BSM-1733A | VITAL SIGN MONITOR | MHX | NIHON KOHDEN CORP. | BSM-1733A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |