FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX - EMS DEFIBRILLATOR
MDR report key: 3812768
·
Received April 25, 2014
Report
- Report Number
- 1218950-2014-02335
- Event Type
- Malfunction
- Date Received
- April 25, 2014
- Report Date
- April 1, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED TO PHILLIPS HEALTHCARE THAT THE HEARTSTART MRX WAS UNABLE READ ECG PROPERLY WITH NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 251154 | HEARTSTART MRX - EMS DEFIBRILLATOR | MKJ | PHILIPS MEDICAL SYSTEMS | M3536A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |