FDA Adverse Event Malfunction Summary report: N

BRITEBLADE PRO

MDR report key: 1945186 · Received December 22, 2010

Report

Report Number
1945186
Event Type
Malfunction
Date Received
December 22, 2010
Date of Event
December 15, 2010
Report Date
December 22, 2010
Manufacturer
FLEXICARE MEDICAL LIMITED
Product Code
CCW
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA, US

Narratives

Description of Event or Problem · 1

DURING AN ATTEMPT TO PLACE AN INTUBATION TUBE DURING A CODE, THE USER RETRIEVED A LARYNGOSCOPE HANDLE AND MAC #3 LARYNGOSCOPE BLADE TO ASSEMBLE FOR ET TUBE PLACEMENT. WHEN THE TWO SECTIONS WERE SNAPPED TOGETHER AND MATED, NO LIGHT WAS EMITTED. SEVERAL ATTEMPTS WERE MADE TO GET THE LAMP TO START, INCLUDING BATTERY POSITION AND RE-INSERTION. THE CODE TEAM HAD TO SCRAMBLE FOR ANOTHER ADULT INTUBATION TRAY TO GET ANOTHER LARYNGOSCOPE SET. THE SECOND SET WORKED AND THE CODE TEAM WAS ABLE TO POSITION THE ET TUBE. AT THE END OF CODE, THE RESPIRATORY THERAPIST TESTED THE KNOWN BAD MAC3 BLADE WITH ANOTHER HANDLE AND THE BLADE LIT. THE THERAPIST ALSO TESTED A DIFFERENT BLADE ONTO THE KNOWN FAILED HANDLE AND THE BLADE LIT; WE CANNOT GET EITHER THE BLADE OR HANDLE TO FAIL WHEN MATCHED WITH A DIFFERENT MATES. STERILE PROCESSING HAS BEEN INSTRUCTED TO TEST THE LIGHT ON THE HANDLE BY PRESSING THE LIGHT HOUSING DOWN UNIT LIT. THE BLADES ARE USUALLY PACKAGED STERILE AND ARE UNABLE TO BE TESTED WITH EACH HANDLE. THESE WERE PURCHASED BY THE MEDICAL CENTER TO AVOID THIS VERY SCENARIO. DISTRIBUTER OF DEVICE CONTACTED FOR MANUFACTURER INFORMATION. THIS IS A RECURRING ISSUE ACCORDING TO THE THERAPISTS.======================HEALTH PROFESSIONAL'S IMPRESSION======================DEVICE FAILED TO WORK DURING A CODE EVENT AND A STAT REPLACEMENT PROCESS HAD TO OCCUR. IT HAS BEEN REPORTED THAT MORE THAN ONE EVENT HAS OCCURRED WITH THIS NEW DISPOSABLE SYSTEM. ======================MANUFACTURER RESPONSE FOR LARYNGOSCOPE, BRIGHT BLADE PRO======================TO HAND OFF INSTRUMENT TO DISTRIBUTER.======================MANUFACTURER RESPONSE FOR LARYNGOSCOPE HANDLE, VENTICAIRE======================RETURN TO DISTRIBUTOR FOR EVALUATION. THIS IS TO BE RETURNED AS A SET ALONG WITH THE BLADE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BRITEBLADE PRO FIBER OPTIC BLADE CCW FLEXICARE MEDICAL LIMITED MACINTOSH SIZE 3 0120
2 VENTICAIRE LARYNGOSCOPE HANDLE CCW FLEXICARE MEDICAL LIMITED UNK CHT

Patients

Seq Age Sex Outcome Treatment
1 * OTHER