FDA Adverse Event
Death
Summary report: N
HEARTSTART MRX - EMS DEFIBRILLATOR
MDR report key: 1841170
·
Received September 16, 2010
Report
- Report Number
- 1218950-2010-01616
- Event Type
- Death
- Date Received
- September 16, 2010
- Date of Event
- August 16, 2010
- Report Date
- August 17, 2010
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO ABOUT THIS EVENT.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE DISARMED UNEXPECTEDLY AFTER ADVISING A SHOCK IN THE AED MODE. THE INVOLVED PT DIED, BUT THE CUSTOMER STATED THAT DEVICE BEHAVIOR DID NOT IMPACT PT OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART MRX - EMS DEFIBRILLATOR | MKJ | PHILIPS HEALTHCARE | M3536A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 YR |