FDA Adverse Event
Malfunction
Summary report: N
CODEMASTER XL
MDR report key: 2935444
·
Received January 3, 2013
Report
- Report Number
- 1218950-2013-00007
- Event Type
- Malfunction
- Date Received
- January 3, 2013
- Report Date
- December 7, 2012
- 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). NO PT INVOLVEMENT WAS REPORTED. NO SYMPTOM WAS PROVIDED THE CUSTOMER STATED IT WAS NOT POSSIBLE TO USE THE MACHINE. WE WILL CONSIDER A MALFUNCTION THAT OCCURRED THAT COULD IMPACT THE DELIVERY OF THERAPY. THE COMPLAINT IS STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
NO PT INVOLVEMENT WAS REPORTED. NO SYMPTOM WAS PROVIDED BUT THE CUSTOMER STATED IT WAS NOT POSSIBLE TO USE THE MACHINE. WE WILL CONSIDER A MALFUNCTION THAT OCCURRED THAT COULD IMPACT THE DELIVERY OF THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 4135 | CODEMASTER XL | LDD, MKJ, DQA | LDD | PHILIPS MEDICAL SYSTEMS | M1723A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |