FDA Adverse Event
Malfunction
Summary report: N
CODEMASTER XL+
MDR report key: 3222097
·
Received July 2, 2013
Report
- Report Number
- 1218950-2013-02799
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Report Date
- June 12, 2013
- 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). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
CUSTOMER STATES DURING ROUTINE MAINTENANCE AN ISSUE WAS DISCOVERED WITH THE POWER SUPPLY. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300679 | CODEMASTER XL+ | LDD, MKJ, DQA | LDD | PHILIPS MEDICAL SYSTEMS | M1722B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |