FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART XL
MDR report key: 3240347
·
Received July 8, 2013
Report
- Report Number
- 1218950-2013-02903
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Report Date
- June 12, 2013
- 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
(B)(4): A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHILE SWITCHING THE PACING MODE THEY WERE GETTING AN ERROR MESSAGE, "SYSTEM CYCLE POWER FAILURE, ERROR CODE 20004." THIS ERROR CODE IS IN THE CATEGORY OF WHEN THE OPERATION OF THE DEVICE IS HALTED. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309254 | HEARTSTART XL | MKJ | PHILIPS MEDICAL SYSTEMS | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |