FDA Adverse Event
Other
Summary report: N
AKRON
MDR report key: 527758
·
Received January 27, 2004
Report
- Report Number
- 3000140091-2004-02737
- Event Type
- Other
- Date Received
- January 27, 2004
- Date of Event
- November 1, 2003
- Report Date
- November 10, 2003
- Manufacturer
- HUNTLEIGH HEALTHCARE LTD., AKRON PRODUCTS DIV.
- Product Code
- FQO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
FAILURE OF HINGE PLATE WELD CAUSING UNEXPECTED MOVEMENT AND DISTORTION IN FOOT SECTION OF COUCH (TABLE). THE PT, WHO WAS ON THE TABLE, FELT THE MOVEMENT AND STEPPED OFF THE TABLE. THE PHOTOGRAPH OF THE HINGE PLATE SHOWS THAT THE PLATE IS STILL ATTACHED, BUT THE WELD HAS PEELD AWAY FROM THE MAIN STRUCTURE. THERE HAVE BEEN TWO FURTHER REPORTS OF THIS PROBLEM (12/2003) FROM A BATCH OF 75 CONTINENTAL COUCHES (TABLES) PRODUCED BY A SUBCONTRACTOR. NO INJURIES HAVE OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AKRON | POWERED TABLE | FQO | HUNTLEIGH HEALTHCARE LTD., AKRON PRODUCTS DIV. | 9232A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |