FDA Adverse Event
Death
Summary report: N
HEARTSTART XL
MDR report key: 3052551
·
Received April 4, 2013
Report
- Report Number
- 1218950-2013-01211
- Event Type
- Death
- Date Received
- April 4, 2013
- Date of Event
- February 20, 2013
- Report Date
- March 11, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THE DEVICE'S ENERGY SELECTION WAS SET TO 150 JOULES. THE DEVICE CHARGED TO 50 JOULES AND THE SCREEN WENT BLANK, GIVING A "POWER FAILURE" MESSAGE, WHICH OCCURRED TWICE. THE PT DIED. THE CUSTOMER WAS UNABLE TO DETERMINE IF THE DEVICE PLAYED A ROLE IN THE PT'S OUTCOME. THE COMPLAINT IS STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE DEVICE'S ENERGY SELECTION WAS SET TO 150 JOULES. THE DEVICE CHARGED TO 50 JOULES AND THE SCREEN WENT BLANK, GIVING A "POWER FAILURE" MESSAGE, WHICH OCCURRED TWICE. THE PT DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 137575 | HEARTSTART XL | MKJ | PHILIPS MEDICAL SYSTEMS | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Death |