FDA Adverse Event
Malfunction
Summary report: N
CODEMASTER XL
MDR report key: 2041398
·
Received March 9, 2011
Report
- Report Number
- 1218950-2011-00634
- Event Type
- Malfunction
- Date Received
- March 9, 2011
- Report Date
- February 16, 2011
- Manufacturer
- AGLIENT TECHNOLOGIES, INC
- Product Code
- LDD
- PMA / PMN Number
- K954957
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THE UNIT FAILED TO CHARGE THE BATTERY. A PHILIPS REP EVALUATED THE DEVICE. THE REPORTED SYMPTOM WAS DUPLICATED. THE BATTERY AND POWER SUPPLY WERE REPLACED. BASED ON THE AVAILABLE INFO, WE COULD NOT DETERMINE THE CAUSE SINCE MULTIPLE PARTS WERE REPLACED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE UNIT FAILED TO CHARGE THE BATTERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CODEMASTER XL | LDD, MKJ, DQA | LDD | AGLIENT TECHNOLOGIES, INC | M1723B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |