MAUDE Adverse Event Report: VERATHON MEDICAL ULC SPECTRUM SMART CABLE; LARYNGOSCOPE

Model Number 0800-0544

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

The device return is anticipated; however, at the time of the report the device has not been received by verathon.

Event Description

The customer reported that during a patient procedure, using a spectrum smart cable, the signal cuts out and the customer will get the message to attach cable.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

• Brand Name: SPECTRUM SMART CABLE
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer (Section G): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer Contact: corey kasbohm ; 20001 n creek pkwy; bothell, wa ; 6295760
• MDR Report Key: 9925614
• MDR Text Key: 189503386
• Report Number: 9615393-2020-00052
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/02/2020

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 Model Number: 0800-0544
• Device Catalogue Number: 0800-0544
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2020
• 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