FDA Adverse Event
Malfunction
Summary report: N
HEART START XL
MDR report key: 3170856
·
Received June 7, 2013
Report
- Report Number
- 1218950-2013-02222
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Report Date
- May 13, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED PADDLES ECG NOISE. THERE WAS NO PT INVOLVEMENT. WE HAVE REQUESTED MORE INFORMATION AND THIS INVESTIGATION REMAINS OPEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253901 | HEART START XL | MKJ | PHILIPS MEDICAL SYSTEMS | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |