FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX - EMS DEFIBRILLATOR
MDR report key: 2896413
·
Received November 20, 2012
Report
- Report Number
- 1218950-2012-03860
- Event Type
- Malfunction
- Date Received
- November 20, 2012
- Report Date
- October 26, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THE MONITOR CAME ON WITH SWITCH IN OFF POSITION, SYNC CAME ON WITHOUT BEING TURNED ON. THERE IS NO REPORTED PT INVOLVEMENT. THE PHILIPS REPAIR BENCH EVALUATED THE DEVICE. NO TROUBLE WAS FOUND. NO REPAIRS WERE NEEDED RELATED TO THIS COMPLAINT. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTING AND WAS RETURNED TO THE CUSTOMER. PHILIPS WAS NOT ABLE TO CONFIRM THE REPORTED MALFUNCTION. NO CAUSE CAN BE DETERMINED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE MONITOR CAME ON WITH SWITCH IN OFF POSITION, SYNC CAME ON WITHOUT BEING TURNED ON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART MRX - EMS DEFIBRILLATOR | MKJ | PHILIPS MEDICAL SYSTEMS | M3536A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |