FDA Adverse Event Malfunction Summary report: N

BRITEPRO SOLO FIBRE OPTIC LARYGOSCOPE HANDLE WITH BATTERIES

MDR report key: 17853192 · Received September 29, 2023

Report

Report Number
MW5146323
Event Type
Malfunction
Date Received
September 29, 2023
Date of Event
September 12, 2023
Report Date
September 26, 2023
Manufacturer
FLEXICARE MEDICAL LTD.
Product Code
CCW
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NC, US
Reporter Occupation
RISK MANAGER
Health Professional
Yes

Narratives

Description of Event or Problem · 0

A VERY PREMATURE DELIVERY WAS PLANNED VIA UNSCHEDULED C-SECTION. WHILE AWAITING RECEIPT OF THE CHILD, THE INTUBATION EQUIPMENT WAS TESTED, ANTICIPATING THE NEED FOR PULMONARY SUPPORT. DISPOSABLE LARYNGOSCOPE HANDLES HAVE BEEN IMPLEMENTED. IT IS OUR PRACTICE THAT THE HANDLES ARE TESTED PRIOR TO DEPLOYMENT IN THE CODE CARTS BY THE CENTRAL STERILE TEAM. AT LEAST 6 DIFFERENT DISPOSABLE HANDLES WOULD NOT WORK. ASSUMING THE POSSIBILITY OF USER ERROR, WE DEPLOYED ADDITIONAL PERSONNEL FOR SUPPORT. SIX HANDLES WITH ATTEMPTS BY MULTIPLE EXPERIENCED NURSES, RESPIRATORY THERAPISTS, PHYSICIANS, CENTRAL STERILE TECHS (WHO TEST THESE ITEMS ROUTINELY), & OTHER OR PERSONNEL ALL WOULD NOT WORK. A REUSABLE HANDLE WAS DEPLOYED, WORKED IMMEDIATELY, & ALL RESUSCITATION EQUIPMENT WAS IN PLACE BEFORE NEEDED. ITEM WAS NOT USED ON PATIENT AND NO HARM TO PATIENT. REFERENCE REPORTS: MW5146320, MW5146321, MW5146322, MW5146324, MW5146325.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
589703 BRITEPRO SOLO FIBRE OPTIC LARYGOSCOPE HANDLE WITH BATTERIES LARYNGOSCOPE, RIGID CCW FLEXICARE MEDICAL LTD. 201102171

Patients

Seq Age Sex Outcome Treatment
1 0 DA Female