FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX
MDR report key: 3150386
·
Received May 31, 2013
Report
- Report Number
- 1218950-2013-02078
- Event Type
- Malfunction
- Date Received
- May 31, 2013
- Report Date
- May 9, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE READY FOR USE (RFU) HOURGLASS IS ON, AND THE DEVICE AUDIO IS WORKING IN AED MODE, HOWEVER, THE DISPLAY SCREEN IS COMPLETELY BLANK. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 240379 | HEARTSTART MRX | MKJ | PHILIPS MEDICAL SYSTEMS | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |