FDA Adverse Event
Malfunction
Summary report: N
CODEMASTER XL
MDR report key: 4791832
·
Received May 22, 2015
Report
- Report Number
- 1218950-2015-02791
- Event Type
- Malfunction
- Date Received
- May 22, 2015
- Report Date
- May 14, 2015
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- LDD
- PMA / PMN Number
- K954957
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE AC OR BATTERY LED INDICATORS ON THE DEVICE ARE NOT LIT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 336306 | CODEMASTER XL | DEFIB/MONITOR | LDD | PHILIPS MEDICAL SYSTEMS | M1723B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |