FDA Adverse Event
Summary report: N
SIEMENS
MDR report key: 308089
·
Received December 7, 2000
Report
- Report Number
- MW1020561
- Date Received
- December 7, 2000
- Date of Event
- October 18, 2000
- Report Date
- December 7, 2000
- Manufacturer
- SIEMENS MEDICAL SYSTEMS INC. ELECTROMEDICAL DIV.
- Product Code
- MHX
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT WITH DIAGNOSIS OF INTRACTIBLE EPILEPSY EXPERIENCED RESPIRATORY DISTRESS NOT ATTRIBUTED TO EPILEPSY CONDITION. PLACED ON SIEMENS BEDSIDE MONITOR. THIS REPORT IS SPECIFIC TO THE PULSE OXIMETRY FUNCTION OF THE SIEMENS MONITOR. OXYGEN SATURATION LEVEL DROPPED BELOW SET PARAMETERS. ALARM DID NOT SOUND. REORTED TO INTERNAL BIOMED DEPT AND SIEMEN'S REP. SIEMENS CAME TO HOSP. UNABLE TO REPLICATE SITUATION. NO FURTHER PROBLEMS WITH EQUIPMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIEMENS | BEDSIDE MONITOR | MHX | SIEMENS MEDICAL SYSTEMS INC. ELECTROMEDICAL DIV. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR |