FDA Adverse Event
Malfunction
Summary report: N
HEART START XL
MDR report key: 1894624
·
Received November 4, 2010
Report
- Report Number
- 1218950-2010-02158
- Event Type
- Malfunction
- Date Received
- November 4, 2010
- Report Date
- October 5, 2010
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED GETTING AN INTERMITTENT ERROR 10004 AND BEING UNABLE TO START UP. THE UNIT WAS EVALUATED AT PHILIPS. THE DEVICE PASSED ALL TESTING, HOWEVER, THE ERROR 10004 WAS NOTED IN THE SYSTEM LOG. THE ERROR 10004 APPEARS WITH A SYSTEM FAILURE, CYCLE POWER MESSAGE WHICH COULD BE INTERPRETED AS BEING UNABLE TO START UP. THE CONTROL PCA WAS REPLACED TO RESOLVE THIS ISSUE AS RECOMMENDED IN THE SERVICE MANUAL. WE ARE CONSIDERING THIS AN INTERMITTENT CONTROL PCA MALFUNCTION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED GETTING AN INTERMITTENT ERROR 10004 AND BEING UNABLE TO START UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEART START XL | MKJ | PHILIPS HEALTHCARE | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |