FDA Adverse Event
Death
Summary report: N
HEART START XL
MDR report key: 3430262
·
Received October 15, 2013
Report
- Report Number
- 1218950-2013-05167
- Event Type
- Death
- Date Received
- October 15, 2013
- Report Date
- October 11, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- 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 TO PHILIPS HEALTHCARE THAT THE DEFIBRILLATOR DID NOT DELIVER A SHOCK TO THE PATIENT AND THE PATIENT DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 526893 | HEART START XL | MKJ | PHILIPS MEDICAL SYSTEMS | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |