FDA Adverse Event
Malfunction
Summary report: N
HEART START XL
MDR report key: 1740924
·
Received June 25, 2010
Report
- Report Number
- 1218950-2010-01024
- Event Type
- Malfunction
- Date Received
- June 25, 2010
- Report Date
- October 13, 2009
- Manufacturer
- AGILENT TECHNOLOGIES, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THAT THE UNIT FAILED TO POWER UP ON AC POWER. THE HOSPITAL BIOMED ORDERED AN AC POWER SUPPLY. AS OF 6/11/10 THERE HAVE BEEN NO FURTHER CALLS FROM THIS CUSTOMER REGARDING THIS FAILURE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE UNIT FAILED TO POWER UP ON AC POWER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEART START XL | MKJ | AGILENT TECHNOLOGIES, INC. | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |