MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD PROVU UNIVERSAL REUSABLE 8" DISPLAY, CHARGING CABLE AND 2 M AMPLIFIER EXTENSION; LARYNGOSCOPE, RIGID

Catalog Number 040-07-0080U

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2024

Event Type  malfunction  

Event Description

The problem as described by "clinician" 'the probe for the provu is not connecting.There was a near miss situation today when it turned off during intubation.'.

• Brand Name: PROVU UNIVERSAL REUSABLE 8" DISPLAY, CHARGING CABLE AND 2 M AMPLIFIER EXTENSION
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE MEDICAL LTD; cwm cynon business park; mountain ash, rct CF45 4ER; UK CF45 4ER
• Manufacturer (Section G): FLEXICARE MEDICAL LTD (CHINA); no.b-15; xicheng industrial zone; dongguan, guangdong 52346 5; CH 523465
• Manufacturer Contact: julie davies ; cwm cynon business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 18941527
• MDR Text Key: 338203042
• Report Number: 3006061749-2024-00012
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 040-07-0080U
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• 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