FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX - EMS DEFIBRILLATOR
MDR report key: 2963016
·
Received January 23, 2013
Report
- Report Number
- 1218950-2013-00252
- Event Type
- Malfunction
- Date Received
- January 23, 2013
- Report Date
- January 3, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED A 12 LEAD FAILURE MESSAGE. THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER EVALUATED THE DEVICE. THE CUSTOMER REPLACED THE TRUNK CABLE AND LEADSET AND THE DEVICE PASSED THE OP CHECK. THE DEVICE WAS THEN SENT INTO THE PHILIPS BENCH FOR EVALUATION. THE REPORTED ERRORS/MESSAGES WERE CONFIRMED. THE MEASUREMENT CONNECTOR WAS ALSO REPLACED PER THE DISCRETION OF THE REPAIR TECHNICIAN. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO THE CUSTOMER. WE CAN NOT DETERMINE THE CAUSE OF THE MALFUNCTION AS MULTIPLE PARTS WERE REPLACED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A 12 LEAD FAILURE MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 33413 | HEARTSTART MRX - EMS DEFIBRILLATOR | MKJ | PHILIPS MEDICAL SYSTEMS | M3536A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |