FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX -EMS DEFIBRILLATOR
MDR report key: 2121254
·
Received May 4, 2011
Report
- Report Number
- 1218950-2011-01269
- Event Type
- Malfunction
- Date Received
- May 4, 2011
- Report Date
- April 14, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHILIPS RECEIVED A SERVICE REPORT INDICATING THERE WAS A FAULTY THERAPY CONNECTOR PIN THAT WAS IDENTIFIED DURING ROUTINE SERVICING. A 3RD PARTY REPRESENTATIVE EVALUATED THE DEVICE, AND THE THERAPY CONNECTOR AND CABLE WERE REPLACED TO RESOLVE THE ISSUE. WE ARE CONSIDERING THIS A MALFUNCTION RELATED TO AN INTERMITTENT ELECTRICAL CONNECTION BETWEEN THE THERAPY CABLE AND THE THERAPY PORT.
Description of Event or Problem · 1
PHILIPS RECEIVED A SERVICE REPORT INDICATING THERE WAS A FAULTY THERAPY CONNECTOR PIN THAT WAS IDENTIFIED DURING ROUTINE SERVICING.
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 |