FDA Adverse Event
Death
Summary report: N
HEARTSTART MRX-EMS DEFIBRILLATOR
MDR report key: 2081641
·
Received April 26, 2011
Report
- Report Number
- 1218950-2011-01133
- Event Type
- Death
- Date Received
- April 26, 2011
- Date of Event
- March 29, 2011
- Report Date
- March 29, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THE BATTERIES DID NOT MAINTAIN THEIR CHARGE DURING A PATIENT EVENT. AT THIS TIME, THERE HAS BEEN NO DETERMINATION AS TO WHETHER THE DEVICE WAS A FACTOR IN THE REPORTED DEATH OF THE PATIENT. 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 THE BATTERIES DID NOT MAINTAIN THEIR CHARGE DURING A PATIENT EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART MRX-EMS DEFIBRILLATOR | MKJ | PHILIPS HEALTHCARE | M3536A | 1029-447-P 1029-336-P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Death |