FDA Adverse Event
Death
Summary report: N
HEARTSTART MRX - EMS DEFIBRILLATOR
MDR report key: 3760684
·
Received April 8, 2014
Report
- Report Number
- 1218950-2014-01936
- Event Type
- Death
- Date Received
- April 8, 2014
- Date of Event
- March 18, 2014
- Report Date
- March 19, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO CONCERNING THIS EVENT.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT SHOCKS WERE DELIVERED TO THE PT BUT THE PRINTED STIRPS FROM THE DEVICE SAID "NO SHOCK DELIVERED". THE INVOLVED PT DIED. THE IMPACT OF THE DEVICE BEHAVIOR ON THE PT OUTCOME HAS NOT YET BEEN REPORTED BY THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210345 | HEARTSTART MRX - EMS DEFIBRILLATOR | MKJ | PHILIPS MEDICAL SYSTEMS | M3536A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Death |