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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE VIDEO BATON 2.0 LARGE; LARYNGOSCOPE, RIGID

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VERATHON MEDICAL ULC GLIDESCOPE VIDEO BATON 2.0 LARGE; LARYNGOSCOPE, RIGID Back to Search Results
Model Number 0570-0382
Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184); Connection Problem (2900)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/10/2021
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 an emergency care procedure, using a glidescope video baton 2.0 large, the image went blank and a message appeared that said the cable was not connected.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.
 
Manufacturer Narrative
The glidescope video baton 2.0 large was returned to verathon for evaluation.A verathon technical service representative evaluated the returned video baton 2.0 and was able to confirm the reported image issue.When connected to known, good, test equipment, the customer's video baton 2.0 intermittently produced green, horizontal lines and flickers.The camera image quality test was performed and failed.The technical service representative attributed the poor image quality to baton failure.Since the glidescope video baton 2.0 large is not repairable, a replacement video baton 2.0 was provided to the customer and the video baton 2.0 used in the procedure was scrapped.Corrective action is not required at this time.Verathon will continue to monitor for trends.
 
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Brand Name
GLIDESCOPE VIDEO BATON 2.0 LARGE
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 Key12122751
MDR Text Key262544942
Report Number9615393-2021-00196
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 06/10/2021
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 Number0570-0382
Device Catalogue Number0570-0398
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2021
Initial Date Manufacturer Received 06/10/2021
Initial Date FDA Received07/06/2021
Supplement Dates Manufacturer Received09/29/2021
Supplement Dates FDA Received10/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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