FDA Adverse Event
Death
Summary report: N
HEARTSTART MRX - EMS DEFIBRILLATOR
MDR report key: 4176748
·
Received October 1, 2014
Report
- Report Number
- 1218950-2014-05903
- Event Type
- Death
- Date Received
- October 1, 2014
- Date of Event
- August 28, 2014
- Report Date
- September 2, 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
- 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
IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE DEVICE FAILED TO ACCURATELY DISPLAY AN ETCO2 READING DURING A PT EVENT. THE INVOLVED PT DIED. THE CUSTOMER DID NOT INDICATE THAT DEVICE BEHAVIOR IMPACTED PT OUTCOME. DURING ASSESSMENT AND TREATMENT BY THE CREW, THE PT CONDITION DETERIORATED AND THE PT WENT INTO CARDIAC ARREST. PT CARE WAS CONTINUED EN ROUTE TO THE HOSPITAL. THE PT WAS ULTIMATELY PRONOUNCED DEAD IN THE ED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 611465 | HEARTSTART MRX - EMS DEFIBRILLATOR | MKJ | PHILIPS MEDICAL SYSTEMS | M3536A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |