FDA Adverse Event
Death
Summary report: N
HEARTSTART MRX
MDR report key: 3892019
·
Received June 17, 2014
Report
- Report Number
- 1218950-2014-03437
- Event Type
- Death
- Date Received
- June 17, 2014
- Date of Event
- May 28, 2014
- Report Date
- May 28, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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 HEARTSTART MRX DEFIBRILLATOR LOST THE PADS ECG WAVEFORM WHILE IN USE ON A PT IN CARDIAC ARREST. THE INVOLVED PT DIED. THE HOSPITAL ED CLINICAL SUPERVISOR STATED THAT THEY ARE UNABLE TO DETERMINE WHETHER THE DEVICE BEHAVIOR IMPACTED THE PT OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 356500 | HEARTSTART MRX | MKJ | PHILIPS MEDICAL SYSTEMS | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Death |