FDA Adverse Event
Injury
Summary report: N
HEART START XL
MDR report key: 3901461
·
Received June 19, 2014
Report
- Report Number
- 1218950-2014-03517
- Event Type
- Injury
- Date Received
- June 19, 2014
- Report Date
- June 12, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE PT REPORTED TISSUE BURN POST SUCCESSFUL SYNCHRONIZED CARDIOVERSIONS WITH A HEARTSTART XL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361822 | HEART START XL | MKJ | MKJ | PHILIPS MEDICAL SYSTEMS | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |