FDA Adverse Event
Death
Summary report: N
HEARTSTART MRX
MDR report key: 3735832
·
Received April 1, 2014
Report
- Report Number
- 1218950-2014-01799
- Event Type
- Death
- Date Received
- April 1, 2014
- Date of Event
- March 10, 2014
- Report Date
- March 11, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A F/U REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO CONCERNING THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED TO PHILIPS HEALTHCARE THAT DURING USE ON A PATIENT, THE HEARTSTART MRX FAILED TO DELIVER MULTIPLE SHOCKS. ANOTHER DEFIBRILLATOR WAS USED AND A SHOCK WAS SUCCESSFULLY DELIVERED, HOWEVER THE PATIENT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 196089 | HEARTSTART MRX | MKJ | PHILIPS MEDICAL SYSTEMS | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |