FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX
MDR report key: 2974516
·
Received January 28, 2013
Report
- Report Number
- 1218950-2013-00271
- Event Type
- Malfunction
- Date Received
- January 28, 2013
- Report Date
- January 2, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED THAT THE DEFIBRILLATOR PLATES WERE NOT WORKING. THIS COULD INDICATE AN ISSUE WITH THE PADDLES. THERE WAS NO REPORTED PT INVOLVEMENT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEFIBRILLATOR PLATES WERE NOT WORKING. THIS COULD INDICATE AN ISSUE WITH THE PADDLES. THERE WAS NO REPORTED PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 38419 | HEARTSTART MRX | MKJ | PHILIPS MEDICAL SYSTEMS | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |