FDA Adverse Event
Malfunction
Summary report: N
CODEMASTER SL+
MDR report key: 3880787
·
Received May 29, 2014
Report
- Report Number
- 1218950-2014-02996
- Event Type
- Malfunction
- Date Received
- May 29, 2014
- Report Date
- May 5, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- LDD
- PMA / PMN Number
- K954957
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED DURING TEST THE DEICE DISPLAYS BATTERY DISCHARGE AND POWER SUPPLY FAILURE. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 316823 | CODEMASTER SL+ | LDD, MKJ, DQA | LDD | PHILIPS MEDICAL SYSTEMS | M1723B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |