MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD. PROVU VIDEO LARYNGOSCOPY DEVICE; LARYNGOSCOPE, RIGID

Device Problems Failure to Power Up (1476); Application Program Problem (2880); Battery Problem (2885)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

The following issues were identified by several physicians during the time frame of (b)(6) 2022.Re: the provu video laryngoscopy device: physicians noted image lag between the laryngoscope blade and the screen, up to a one second delay.Other cases of image lag were noted to be 3 frames per 5 seconds.Physicians noted that the significant image lag between picture and real time make it challenging to navigate procedures.Physicians also noted image cable cord issues with this device.Cords have failed at the time of need causing delayed intubation to obtain new image cable cords.Physicians noted multiple instances of the unreliability of the device as video going out and coming back on or video going out and then never coming back on at all delaying treatment.Upon investigation, physicians reported over 15 different instances of varied problems with this device during this time frame.Physicians reported the following specific examples: one case had to intubate due to a respiratory failure.The patient was obese with a difficult airway and no reserve.The provu vl worked during pre-check, but when they went to intubate, it froze.They restarted it, but it froze again.They then attempted dl/bougie but were unsuccessful.Other physicians were called and they found a second provu vl that did work.During all this, the patient became hypoxic several times (lowest was 69%) requiring bvm.In another case of intubation, there was a failure to reboot with a persistent blue screen.This resulted in usage of dl with a traditional laryngoscope as it was working before rsi meds were pushed and went blue after the patient was induced.Therefore, there was no time to obtain a backup machine.During 2 active intubations, multiple failures of the device occurred: during one procedure the screen would lag several seconds or skip and during another instance, the device would not boot up at all.A patient arrived and immediately coded.During initial resuscitation, the screen said it was loading.When it finally loaded, cords in view and the screen turned off.Physician went direct after that.Another time, the device wouldn't turn on and shortly after gi bleeder threw up and then coded.Physician went direct after that.While intubating a head bleed patient, the first scope they attempted to use had a screen lag time and was very choppy.They plugged in a second scope and it displayed a low battery screen with 2% power and would not show an image.Although the battery was low, once it was plugged in, it failed to show an image while the battery was charging.During care of a morbidly obese, hypercarbic patient, the device was tested prior to induction.During the procedure, the device screen went blank and the screen said "loading" just after insertion of the blade.Multiple unsuccessful attempts with dl ad bougie.The team finally obtained a second provu vl.The patient desaturated briefly but was never bradycardic or bagged.One physician stated the video stopped working on two occasions as the team was about to intubate.Both times, an rn had to hold the power cord firmly against the back of it to make sure the connection was secure.Due to these issues, this physician opens using a dl due to the unreliability of the provu vl device and fear of losing the picture at a key moment.In another instance, the video froze on one tower and they had to obtain another tower to complete the procedure.Broncoflex agile - slim (220 degree view).

• Brand Name: PROVU VIDEO LARYNGOSCOPY DEVICE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE MEDICAL LTD.
• MDR Report Key: 16264493
• MDR Text Key: 308458990
• Report Number: MW5114544
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/25/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROVU STYLET
• Patient Outcome(s): Life Threatening; Other