FDA Adverse Event
Malfunction
Summary report: N
HEART START XL
MDR report key: 4821403
·
Received June 5, 2015
Report
- Report Number
- 1218950-2015-03024
- Event Type
- Malfunction
- Date Received
- June 5, 2015
- Report Date
- May 15, 2015
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER ADDRESSED PHILIPS BECAUSE TROUBLESHOOTING SHOWED THAT SWITCH OF THE DEVICE WAS DEFECTIVE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 364118 | HEART START XL | DEFIBRILLATOR | MKJ | PHILIPS MEDICAL SYSTEMS | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |