MAUDE Adverse Event Report: FLEXICARE MEDICAL DONGGUAN PROVU RESUABLE 3.5" VIDEO LARYNGOSCOPE MONITOR AND CHARGING DOCK

Catalog Number 040-07-0035U

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/22/2022

Event Type  malfunction  

Event Description

As described in complaint information: 'an emergency patient case arrived at the er and the crna on staff attempted twice to perform an intububation with the provu.Both times the blade connected and showed an image, but upon entering the patients airway for visulaization the device error'd and presenting the error screen with the peron holding a manual and asking for a 5 second power off.Upon powering the device off, as requested, the device completely shut off and would not turn back on.Addiotnally the clinican had to switch to a regualr laryngoscope for intubation as the patient was in dire need of intubation after the failure of the provu.'.

• Brand Name: PROVU RESUABLE 3.5" VIDEO LARYNGOSCOPE MONITOR AND CHARGING DOCK
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section G): FLEXICARE MEDICAL DONGGUAN; no. b-15 xicheng ind zone 1; hengli town; dongguan city, ; CH
• Manufacturer Contact: julie davies ; cynon valley business park; mountain ash, rct CF454-ER ; UK CF454ER
• MDR Report Key: 15265123
• MDR Text Key: 305258909
• Report Number: 3006061749-2022-00014
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 040-07-0035U
• Device Lot Number: SUTJ51198
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention