FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX-EMS DEFIBRILLATOR
MDR report key: 3489875
·
Received September 25, 2013
Report
- Report Number
- 1218950-2013-04689
- Event Type
- Malfunction
- Date Received
- September 25, 2013
- Report Date
- August 28, 2013
- 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 PHILIPS HEALTHCARE THAT THE HEARTSTART MRX FAILED OPCHECK WITH A FAILED D/DX FAILURE RESULTS FOLLOWED BY RED X AND BEEPING. THERE WAS NO REPORTED PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 485519 | HEARTSTART MRX-EMS DEFIBRILLATOR | MKJ | PHILIPS MEDICAL SYSTEMS | M3536A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |