FDA Adverse Event
Other
Summary report: N
TRANSCAM
MDR report key: 1760577
·
Received June 29, 2010
Report
- Report Number
- 2916556-2010-00002
- Event Type
- Other
- Date Received
- June 29, 2010
- Report Date
- March 15, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
- Product Code
- KPS
- PMA / PMN Number
- K921296
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY A THIRD-PARTY VENDOR, (B)(6), SERVICES THIS CAMERA. THE CUSTOMER HAS BEEN INSTRUCTED TO NOT USE THE CAMERA BY (B)(6). THIS SYSTEM WAS END-OF-LIFED (EOL) BY PHILIPS MEDICAL SYSTEMS IN (B)(6) 2009. IF THE SCREWS SUPPORTING THE DETECTOR ARE REMOVED THEY SHOULD BE REINSTALLED PER CURRENT PROCEDURE. A CAPA NOTIFICATION WENT OUT 11/17/1998 TO PHILIPS (B)(4) FIELD SERVICE TO "ALWAYS ADD THREADLOCKING FLUID TO ALL BOLTS: (B)(4). THE USE/INSTALLATION OF HELI-COILS TO REPAIR ANY WEAR CAN BE DONE WITHOUT A PROCEDURE AS IT IS COMMON IN THIS INDUSTRY. (B)(4).
Description of Event or Problem · 1
THE SCREWS HOLDING THE DETECTOR ONTO THE SUPPORT ARM ARE STRIPPED. THERE IS CONCERN THAT THE DETECTOR WILL FALL OFF THE MACHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSCAM | TRANSCAM | KPS | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. | 5200-2338 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |