FDA Adverse Event
Malfunction
Summary report: N
HEARTSTREAM XL
MDR report key: 1080550
·
Received July 17, 2008
Report
- Report Number
- 1218950-2008-00409
- Event Type
- Malfunction
- Date Received
- July 17, 2008
- Report Date
- June 18, 2008
- Manufacturer
- AGILENT TECHNOLOGIES, INC.
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FACTORY HAS NOT YET RECEIVED THE DEVICE FOR EVALUATION, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHEN 200 JOULES WERE SELECTED, 150 JOULES WERE DISPLAYED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTREAM XL | DEFIBRILLATOR | MKJ | AGILENT TECHNOLOGIES, INC. | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |