FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX - EMS DEFIBRILLATOR
MDR report key: 2082703
·
Received April 28, 2011
Report
- Report Number
- 1218950-2011-01192
- Event Type
- Malfunction
- Date Received
- April 28, 2011
- Report Date
- April 5, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT DURING A PREVENTIVE MAINTENANCE TEST, THE DEFIBRILLATOR WAS TESTED AND FOUND TO HAVE A HIGH PACER OUTPUT. THIS 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 THAT DURING A PREVENTIVE MAINTENANCE TEST, THE DEFIBRILLATOR WAS TESTED AND FOUND TO HAVE A HIGH PACER OUTPUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART MRX - EMS DEFIBRILLATOR | MKJ | PHILIPS HEALTHCARE | M3536A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |