FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART XL
MDR report key: 3192463
·
Received June 19, 2013
Report
- Report Number
- 1218950-2013-02452
- Event Type
- Malfunction
- Date Received
- June 19, 2013
- Report Date
- May 20, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED AC POWER MODULE STOPPED WORKING AND THAT THE BATTERY IS DISCHARGED ALL THE WAY DOWN WITH A RESULTING LOSS OF SYSTEM SETTINGS. THERE WAS NO REPORT OF PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279301 | HEARTSTART XL | MKJ | PHILIPS MEDICAL SYSTEMS | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |