FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX - EMS DEFIBRILLATOR
MDR report key: 2860472
·
Received November 5, 2012
Report
- Report Number
- 1218950-2012-03677
- Event Type
- Malfunction
- Date Received
- November 5, 2012
- Report Date
- October 11, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THE MONITOR IS NOT SHOWING CORRECT LEADS. WHEN TRYING TO SWITCH LEADS, UNIT POWERED DOWN TWICE. THERE WAS NO REPORTED ADVERSE PT IMPACT. THE COMPLAINT IS STILL UNDER INVESTIGATION. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE MONITOR IS NOT SHOWING CORRECT LEADS. WHEN TRYING TO SWITCH LEADS, UNIT POWERED DOWN TWICE. THERE WAS NO REPORTED ADVERSE PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART MRX - EMS DEFIBRILLATOR | MKJ | PHILIPS MEDICAL SYSTEMS | M3536A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |