MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD PROVU UNIVERSAL REUSABLE 2M AMPLIFIER EXTENSION CABLE; LARYNGOSCOPE

Catalog Number 040-07-0020U

Device Problem Insufficient Information (3190)

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

Event Date 12/06/2022

Event Type  malfunction  

Event Description

Details of the event as described in the product event report 'md connected mac4vl blade to the cable and began to intubate.A brief period later, the image on the 8" monitor froze.Md disconnected the cable and used a 3.5" monitor to saefly intubate the patient.'.

• Brand Name: PROVU UNIVERSAL REUSABLE 2M AMPLIFIER EXTENSION CABLE
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): FLEXICARE MEDICAL LTD; cynon valley business park; mountain ash, rct CF454 ER; UK CF454ER
• Manufacturer (Section G): FLEXICARE MEDICAL DONGGUAN; no.b-15 xicheng ind. zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• Manufacturer Contact: julie davies ; cynon valley business park; mountain ash, rct ; UK
• MDR Report Key: 16041491
• MDR Text Key: 306414331
• Report Number: 3006061749-2022-00027
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2022

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?: No
• Device Catalogue Number: 040-07-0020U
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1