FDA Adverse Event
Death
Summary report: N
HEARTSTART MRX - EMS DEFIBRILLATOR
MDR report key: 1723345
·
Received June 11, 2010
Report
- Report Number
- 1218950-2010-00900
- Event Type
- Death
- Date Received
- June 11, 2010
- Date of Event
- May 12, 2010
- Report Date
- May 13, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS EVALUATED AT PHILIPS, AND THE REPORTED SYMPTOM WAS VERIFIED. REPLACING THE PROCESSOR PCA AND THE INTERNAL MEMORY CARD RESOLVED THE REPORTED ISSUE. THE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE MORE THAN ONE PART WAS REPLACED. THE DEVICE PASSED ALL PERFORMANCE EVAL TESTING AND WAS RETURNED TO THE CUSTOMER. (B) (6) .
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING ONE PT EVENT THEY WERE UNABLE TO ACQUIRE PADS ECG VIEW DURING A CARDIAC ARREST (SEE MFR REPORT # 1218950-2010-00901 / COMPLAINT # (B) (4)) AND THE DEVICE SHUT DOWN UNEXPECTEDLY. THE CUSTOMER STATED THAT DEVICE BEHAVIOR DID NOT IMPACT PT OUTCOME. THIS REPORT ADDRESSES THE UNEXPECTED SHUTDOWN.
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 | Death |