FDA Adverse Event
Death
Summary report: N
HEARTSTART XL+ DEFIBRILLATOR/MONITOR
MDR report key: 3603944
·
Received January 23, 2014
Report
- Report Number
- 1218950-2014-00361
- Event Type
- Death
- Date Received
- January 23, 2014
- Date of Event
- January 18, 2014
- Report Date
- January 20, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K110825
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO CONCERNING THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED TO PHILIPS HEALTHCARE THAT DURING PT CARE, THE HEARTSTART XL+, WHICH WAS SET TO MANUAL MODE AND CHARGED TO 200 JOULES, DID NOT SHOCK THE PT. ANOTHER DEFIBRILLATOR WAS USED TO SHOCK THE PT. THE STAFF ADMINISTERED CPR, HOWEVER THE PT SUBSEQUENTLY DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 54666 | HEARTSTART XL+ DEFIBRILLATOR/MONITOR | MKJ | PHILIPS MEDICAL SYSTEMS | 861290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |