FDA Adverse Event
Death
Summary report: N
HEARTSTART MRX
MDR report key: 4170515
·
Received September 29, 2014
Report
- Report Number
- 1218950-2014-05867
- Event Type
- Death
- Date Received
- September 29, 2014
- Date of Event
- September 19, 2014
- Report Date
- September 22, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- 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 THAT THE HEARTSTART MRX DEFIBRILLATOR SHOWED A SHOCK DEVICE MALFUNCTION ERROR AND WAS MADE TO SHOCK DURING A PT CODE. THE PT DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607172 | HEARTSTART MRX | MKJ | PHILIPS MEDICAL SYSTEMS | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |