FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX -EMS DEFIBRILLATOR
MDR report key: 1033041
·
Received April 22, 2008
Report
- Report Number
- 1218950-2008-00234
- Event Type
- Malfunction
- Date Received
- April 22, 2008
- Report Date
- March 24, 2008
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- LDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PARAMEDIC
Narratives
Additional Manufacturer Narrative · 1
THE FACTORY HAS NOT YET RECEIVED THE DEVICE FOR EVALUATION, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE THERAPY CABLE HAS A SHORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART MRX -EMS DEFIBRILLATOR | DEFIBRILLATOR | LDD | PHILIPS MEDICAL SYSTEMS | M3536A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |