FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX
MDR report key: 2823623
·
Received October 9, 2012
Report
- Report Number
- 1218950-2012-03369
- Event Type
- Malfunction
- Date Received
- October 9, 2012
- Report Date
- September 18, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A PACEMAKER ERROR. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
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 |