FDA Adverse Event
Death
Summary report: N
HEARTSTART MRX
MDR report key: 2112429
·
Received May 24, 2011
Report
- Report Number
- 1218950-2011-01458
- Event Type
- Death
- Date Received
- May 24, 2011
- Date of Event
- April 25, 2011
- Report Date
- April 28, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED THAT DURING A PT EVENT THE CHARGE BUTTONS WAS PRESSED AND THE DEVICE DID NOT CHARGE AS EXPECTED. THE CUSTOMER SWITCHED TO A DIFFERENT DEFIBRILLATOR TO DELIVER THERAPY. THE INVOLVED PT DIED, BUT THE CUSTOMER REPORTED THAT THE DEVICE BEHAVIOR DID NOT CONTRIBUTE TO THE PT OUTCOME. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION ABOUT THIS EVENT.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A PT EVENT THE CHARGE BUTTON WAS PRESSED AND THE DEVICE DID NOT CHARGE AS EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART MRX | MKJ | PHILIPS HEALTHCARE | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |