FDA Adverse Event
Malfunction
Summary report: N
HEARTSTREAM XL
MDR report key: 1243009
·
Received November 20, 2008
Report
- Report Number
- 1218950-2008-00639
- Event Type
- Malfunction
- Date Received
- November 20, 2008
- Report Date
- October 4, 2008
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO POWER UP DURING THE SHIFT CHECK. A PHILIPS FIELD SUPPORT ENGINEER EVALUATED THE DEVICE AT THE CUSTOMER SITE AND REPLACED THE ENERGY SELECT SWITCH TO RESOLVE THE ISSUE. WE ARE CONSIDERING THIS FAILURE A MALFUNCTION OF THE ENERGY SELECT SWITCH ASSEMBLY.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO POWER UP DURING THE SHIFT CHECK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTREAM XL | MKJ | PHILIPS MEDICAL SYSTEMS | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |