PROVU
Report
- Report Number
- 3006061749-2025-00058
- Event Type
- Malfunction
- Date Received
- October 21, 2025
- Date of Event
- October 16, 2025
- Report Date
- April 8, 2026
- Manufacturer
- FLEXICARE MEDICAL LTD
- Product Code
- BTR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
NA.
THE RETURNED SAMPLE WAS EVALUATED, AND THE USB PORT OF THE MONITOR WAS FOUND TO BE CRACKED. TESTING CONDUCTED UNDER NORMAL OPERATING CONDITIONS DID NOT REPRODUCE THE REPORTED ISSUE. THE FORCE REQUIRED TO ADJUST THE MONITOR STAND DURING NORMAL USE WAS FOUND TO BE INSUFFICIENT TO CAUSE DAMAGE TO THE USB PORT. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMS THE CORRECT METHOD FOR CONNECTING AND OPERATING THE DEVICE. BASED ON THE AVAILABLE INFORMATION AND INVESTIGATION FINDINGS, IT IS CONSIDERED LIKELY THAT THE DAMAGE OCCURRED WHEN FORCE WAS APPLIED BEYOND THE INTENDED OPERATING LIMITS OF THE DEVICE DURING USE. NO EVIDENCE OF A DESIGN, MANUFACTURING, OR MATERIAL DEFECT WAS IDENTIFIED DURING THE INVESTIGATION. THE ISSUE APPEARS TO BE ASSOCIATED WITH USE CONDITIONS OUTSIDE OF THOSE SPECIFIED IN THE IFU.
CONCLUSION OF ROOT CAUSE AFTER WE HAVE PERFORMED INCIDENT INVESTIGATION.
CONCLUSION OF ROOT CAUSE AFTER WE HAVE PERFORMED INCIDENT INVESTIGATION. THIS IS COVERED BY AN EXISTING SCAR (SCAR-120). AWAITING RESULTS OF INVESTIGATION.
CONCLUSION OF ROOT CAUSE AFTER WE HAVE PERFORMED INCIDENT INVESTIGATION.
"A PROVU 3.5 INCH MONITOR FAILED DURING INTUBATION. THE SCREEN WENT ORANGE AND RED, A NEW BLADE WAS TRIED AND THE SCREEN GAVE A 3 SYMBOL ERROR MESSAGE SN IS (B)(6). NO REPORT OF SERIOUS INJURY / HARM TO PATIENT OR USER. NO REPORT OF INDIRECT HARM. NO REPORT OF REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE. NO REPORT OF HOSPITALISATION - INITIAL OR STAY PROLONGED BY 1 DAY OR MORE. NO REPORT OF SERIOUS INJURY, DISABILITY OR PERMANENT IMPAIRMENT. NOT REPORTED AS LIFE THREATENING. NO DEATH REPORTED. NOTE: PATIENT HAD VOMIT-BLOCKED AIRWAY BUT THE BLADE WASN'T DEEP ENOUGH FOR THAT TO INTERFERE.
A PROVU 3.5 INCH MONITOR FAILED DURING INTUBATION. THE SCREEN WENT ORANGE AND RED, A NEW BLADE WAS TRIED AND THE SCREEN GAVE A 3 SYMBOL ERROR MESSAGE. SN IS (B)(6). NO REPORT OF SERIOUS INJURY / HARM TO PATIENT OR USER, NO REPORT OF INDIRECT HARM, NO REPORT OF REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE, NO REPORT OF HOSPITALISATION - INITAL OR STAY PROLONGED BY 1 DAY OR MORE, NO REPORT OF SERIOUS INJURY, DISABILITY OR PERMANENT IMPAIRMENT, NOT REPORTED AS LIFE THREATENING, NO DEATH REPORTED. NOTE: PATIENT HAD VOMIT-BLOCKED AIRWAY BUT THE BLADE WASNT DEEP ENOUGH FOR THAT TO INTERFERE.
"A PROVU 3.5 INCH MONITOR FAILED DURING INTUBATION. THE SCREEN WENT "ORANGE" AND RED, A NEW BLADE WAS TRIED AND THE SCREEN GAVE A 3 SYMBOL ERROR MESSAGE SN IS (B)(6). NO REPORT OF SERIOUS INJURY / HARM TO PATIENT OR USER. NO REPORT OF INDIRECT HARM. NO REPORT OF REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE. NO REPORT OF HOSPITALISATION - "INITIAL" OR STAY PROLONGED BY 1 DAY OR MORE. NO REPORT OF SERIOUS INJURY, DISABILITY OR PERMANENT IMPAIRMENT . NOT REPORTED AS LIFE THREATENING. NO DEATH REPORTED. NOTE: PATIENT HAD VOMIT-BLOCKED AIRWAY BUT THE BLADE "WASN'T" DEEP ENOUGH FOR THAT TO INTERFERE.
A PROVU 3.5 INCH MONITOR FAILED DURING INTUBATION. THE SCREEN WENT ORANGE AND RED, A NEW BLADE WAS TRIED AND THE SCREEN GAVE A 3 SYMBOL ERROR MESSAGE. SN IS (B)(6). NO REPORT OF SERIOUS INJURY / HARM TO PATIENT OR USER NO REPORT OF INDIRECT HARM NO REPORT OF REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE NO REPORT OF HOSPITALISATION - INITAL OR STAY PROLONGED BY 1 DAY OR MORE NO REPORT OF SERIOUS INJURY, DISABILITY OR PERMANENT IMPAIRMENT NOT REPORTED AS LIFE THREATENING NO DEATH REPORTED. NOTE: PATIENT HAD VOMIT-BLOCKED AIRWAY BUT THE BLADE WASN'T DEEP ENOUGH FOR THAT TO INTERFERE.
A PROVU 3.5 INCH MONITOR FAILED DURING INTUBATION. THE SCREEN WENT ORANGE AND RED, A NEW BLADE WAS TRIED AND THE SCREEN GAVE A 3 SYMBOL ERROR MESSAGE. SN IS (B)(6). NO REPORT OF SERIOUS INJURY / HARM TO PATIENT OR USER. NO REPORT OF INDIRECT HARM. NO REPORT OF REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE. NO REPORT OF HOSPITALISATION - INITIAL OR STAY PROLONGED BY 1 DAY OR MORE. NO REPORT OF SERIOUS INJURY, DISABILITY OR PERMANENT IMPAIRMENT. NOT REPORTED AS LIFE THREATENING. NO DEATH REPORTED. NOTE: PATIENT HAD VOMIT-BLOCKED AIRWAY BUT THE BLADE WASNT DEEP ENOUGH FOR THAT TO INTERFERE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 410484 | PROVU | PROVU REUSABLE 3.5" VIDEO LARYNGOSCOPE MONITOR AND CHARGING DOCK | BTR | FLEXICARE MEDICAL LTD | SUTJ51405 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |