FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX
MDR report key: 2894301
·
Received November 16, 2012
Report
- Report Number
- 1218950-2012-03803
- Event Type
- Malfunction
- Date Received
- November 16, 2012
- Report Date
- October 25, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): DEVICE GIVES PACER EQUIPMENT ERROR, SHOCK ERROR, AND OPCHECK ERROR. THE ANDOVER BENCH CONFIRMED THE DEVICE PACER, SHOCK, AND OPCHECK ISSUES. THERE WAS NO PT INVOLVEMENT WITH THIS ISSUE. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
DEVICE GIVES PACER EQUIPMENT ERROR, SHOCK ERROR, AND OPCHECK ERROR. THE ANDOVER BENCH CONFIRMED THE DEVICE PACER, SHOCK, AND OPCHECK ISSUES. THERE WAS NO PT INVOLVEMENT WITH THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART MRX | MKJ | PHILIPS MEDICAL SYSTEMS | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |