FDA Adverse Event
Injury
Summary report: N
HEARTSTART MRX
MDR report key: 4036349
·
Received August 18, 2014
Report
- Report Number
- 1218950-2014-04977
- Event Type
- Injury
- Date Received
- August 18, 2014
- Date of Event
- August 13, 2014
- Report Date
- August 13, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PR#: (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.
Description of Event or Problem · 1
THE CUSTOMER CONTACTED PHILIPS HEALTHCARE TO REPORT THAT DURING THERAPY, THE PATIENT SUSTAINED A "BURN". THE DEGREE OF BURN AND DETAILS RELATED TO THIS INCIDENT AND TREATMENT OF THE BURN HAVE NOT YET BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 495272 | HEARTSTART MRX | MKJ | PHILIPS MEDICAL SYSTEMS | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |