FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX -EMS DEFIBRILLATOR
MDR report key: 2902881
·
Received November 29, 2012
Report
- Report Number
- 1218950-2012-03959
- Event Type
- Malfunction
- Date Received
- November 29, 2012
- Report Date
- November 6, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED A FAILURE TO ACQUIRE 12 LEAD ECG. THE DEVICE WAS SENT TO THE PHILIPS BENCH FOR EVAL. THE REPORTED SYMPTOM COULD BE REPRODUCED. THE ISSUE WAS ISOLATED TO A WORN ECG CONNECTOR. THERE WAS NO NEGATIVE PT IMPACT. THE ECG CONNECTOR WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO THE CUSTOMER SITE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A FAILURE TO ACQUIRE 12 LEAD ECG. THE DEVICE WAS SENT TO THE PHILIPS BENCH FOR EVAL.
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 |