FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX
MDR report key: 2506991
·
Received March 14, 2012
Report
- Report Number
- 1218950-2012-00913
- Event Type
- Malfunction
- Date Received
- March 14, 2012
- Report Date
- February 16, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS - DUP
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THE UNIT INTERMITTENTLY DISPLAYS A RED X AND THAT THEY RECEIVED TWO CHARGE/SHOCK FAILURE IN RUN TIME MODE. THE DEVICE PASSED OPCHECK. 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 UNIT INTERMITTENTLY DISPLAYS A RED X AND THAT THEY RECEIVED TWO CHARGE/SHOCK FAILURE IN RUN TIME MODE. THE DEVICE PASSED OPCHECK. THERE WAS NO REPORTED PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART MRX | MKJ | PHILIPS MEDICAL SYSTEMS - DUP | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |