FDA Adverse Event
Malfunction
Summary report: N
HEARTSTREAM XL
MDR report key: 1422229
·
Received March 20, 2009
Report
- Report Number
- 1218950-2009-00302
- Event Type
- Malfunction
- Date Received
- March 20, 2009
- Report Date
- February 19, 2009
- Manufacturer
- AGILENT TECHNOLOGIES, INC
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THAT THE DEVICE HAD NO DISPLAY. THE FACTORY HAS NOT YET RECEIVED THE DEVICE FOR EVALUATION, AND THE COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE HAD NO DISPLAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTREAM XL | MKJ | AGILENT TECHNOLOGIES, INC | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |