FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX - EMS DEFIBRILLATOR
MDR report key: 1811447
·
Received August 17, 2010
Report
- Report Number
- 1218950-2010-01327
- Event Type
- Malfunction
- Date Received
- August 17, 2010
- Report Date
- July 19, 2010
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED SPONTANEOUS DISCHARGE OF CHARGED ENERGY IN THE AED MODE. ADDITIONAL ENERGY WAS DELIVERED AS EXPECTED DURING THE CODE. THERE IS NO INDICATION THAT THE INVOLVED PT REQUIRED ADDITIONAL TREATMENT DUE TO DEVICE BEHAVIOR. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED SPONTANEOUS DISCHARGE OF CHARGED ENERGY IN THE AED MODE. ADDITIONAL ENERGY WAS DELIVERED AS EXPECTED DURING THE CODE. THERE IS NO INDICATION THAT THE INVOLVED PT REQUIRED ADDITIONAL TREATMENT DUE TO DEVICE BEHAVIOR.
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 |