FDA Adverse Event
Malfunction
Summary report: N
FLYTE LIGHTED HELMET BP
MDR report key: 2496663
·
Received March 15, 2012
Report
- Report Number
- 1811755-2012-00966
- Event Type
- Malfunction
- Date Received
- March 15, 2012
- Date of Event
- February 20, 2012
- Report Date
- February 20, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- FXZ
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER AND AN INVESTIGATION IS ANTICIPATED. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE INVESTIGATION RESULTS REQUIRE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SETUP FOR A SURGICAL PROCEDURE, FIBERS WERE BLOWING OUT OF THE HELMET¿S AIR CIRCULATION VENT. BACKUP EQUIPMENT WAS AVAILABLE TO COMPLETE THE SCHEDULED PROCEDURE, WITHOUT CAUSING A DELAY. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLYTE LIGHTED HELMET BP | FXZ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |