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

Model Number 0800-0544

Device Problems No Display/Image (1183); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/02/2020

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.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

The customer reported that during a patient procedure, using a spectrum smart cable, the picture went out.No damage to the cable was noted.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

Manufacturer Narrative

D10, g4, g7, h2, h3, h6, h10.The spectrum smart cable was returned to verathon for evaluation.A verathon technical service representative evaluated the returned spectrum smart cable and no abnormalities were discovered.The reported fault could not be reproduced; the unit functioned as intended.The spectrum smart cable was returned to the customer.No further investigation is required at this time.Verathon will continue to monitor for trends.

• Brand Name: SPECTRUM SMART CABLE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• MDR Report Key: 9845715
• MDR Text Key: 189994145
• Report Number: 9615393-2020-00038
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Date Manufacturer Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1