FDA Adverse Event
Other
Summary report: N
AGILENT TECHNOLOGIES
MDR report key: 343820
·
Received July 27, 2001
Report
- Report Number
- 343820
- Event Type
- Other
- Date Received
- July 27, 2001
- Date of Event
- May 14, 2000
- Report Date
- June 16, 2001
- Manufacturer
- AGILENT TECHNOLOGIES
- Product Code
- DXN
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT UNDERWENT OPEN HEART SURGERY AND AT THE END OF THE CASE THE AUTOMATIC BP WAS FOUND TO BE INFLATED FOR AN UNKNOWN PERIOD OF TIME. ARM WAS SWOLLEN, FINGERS WERE BLUE, AND BLISTERS AND HEMATOMAS WERE NOTED ON SKIN. STAFF (CRNA'S) DID NOT ACTIVATE BP MODULE DURING THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 33910 | AGILENT TECHNOLOGIES | AUTOMATIC BP CUFF MODULE | DXN | AGILENT TECHNOLOGIES | M1008B | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Other |