FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX -EMS DEFIBRILLATOR
MDR report key: 2233079
·
Received July 26, 2011
Report
- Report Number
- 1218950-2011-02129
- Event Type
- Malfunction
- Date Received
- July 26, 2011
- Report Date
- June 30, 2011
- Manufacturer
- PHILIPS HEALTHCARE - ANDOVER
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A PHILIPS FSE WENT TO THE CUSTOMER SITE AND VERIFIED THE FAILURE. THERE WERE TWO LOOSE CABLE CONNECTIONS. THE CABLES WERE RESEATED AND THE BATTERY PCA WAS ALSO REPLACED. DUE TO THE FIELD SERVICE ENGINEER FINDING 2 LOOSE CONNECTIONS AND ALSO REPLACING THE BATTERY PCA WE CANNOT DETERMINE THE CAUSE OF THIS REPORTED FAILURE. THE UNIT PASSED ALL POST-SERVICING TESTING AND REMAINS AT THE CUSTOMER SITE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO DETECT THE BATTERY IN ONE OF THE BATTERY COMPARTMENTS. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART MRX -EMS DEFIBRILLATOR | MKJ | PHILIPS HEALTHCARE - ANDOVER | M3536A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |