FDA Adverse Event
Malfunction
Summary report: N
MAXISKY 600
MDR report key: 2223430
·
Received June 23, 2011
Report
- Report Number
- 9681684-2011-00049
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Date of Event
- January 1, 2011
- Report Date
- May 25, 2011
- Manufacturer
- BHM MEDICAL, INC.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
ONE OF THE FIXED TRACKS OF THE INSTALLATION HAS BECOME LOOSE AND HAS MOVED AWAY FROM THE WALL, BECOMING DISCONNECTED FROM THE TRACK BRACKET. NO PATIENT FALL OCCURRED, NO INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXISKY 600 | MANUFACTURED CEILING FIXED CASSETTES | FSA | BHM MEDICAL, INC. | XY TRACKING |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |