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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALTER LABS SALTER LABS; BX20 - PEDIATRIC DISPOSABLE HANDLE 23BATTERY
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SALTER LABS SALTER LABS; BX20 - PEDIATRIC DISPOSABLE HANDLE 23BATTERY Back to Search Results
Model Number 2016.C
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 04/28/2021
Event Type  malfunction  
Manufacturer Narrative
During intubation, the rt attempted to assemble the purple disposable laryngoscope handle and blade for the md.Three separate handles and blades were tested and none of the lights were working.Two size 1 miller blades and one size 0 blade were tested.Patient was being manually ventilated with a bag mask at the time.The blades and handles were determined to be the issue for the delayed intubation in a critical situation.Based on the reported information the criteria for reporting an adverse event have been met.
 
Event Description
During an intubation the rt attempted to assemble the purple disposable laryngoscope handle and blade for the md.Three separate handles and blades were tested and none of the lights were working.Two size 1 miller blades and one size 0 blade were tested.Patient was being manually ventilated with a bag mask at the time.
 
Manufacturer Narrative
Issue has been tied to the design change that derived from a continuous improvement project.The project shifted the pediatric handle to contain 3-batteries rather than 2-batteries, which was manufactured after february 2020.This change was meant to increase shelf life and improve performance.Ra: per the risk analysis filed (ra-08) the severity of harm associated with this complaint is considered 6-major which does not meet the risk threshold for carb review (8-serious).
 
Event Description
During an intubation the rt attempted to assemble the purple disposable laryngoscope handle and blade for the md.Three separate handles and blades were tested and none of the lights were working.Two size 1 miller blades and one size 0 blade were tested.Patient was being manually ventilated with a bag mask at the time.
 
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Brand Name
SALTER LABS
Type of Device
BX20 - PEDIATRIC DISPOSABLE HANDLE 23BATTERY
Manufacturer (Section D)
SALTER LABS
30 spur drive
el paso TX 79906
MDR Report Key11826265
MDR Text Key253501234
Report Number3000219639-2021-00010
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 05/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number2016.C
Device Catalogue Number2016.C
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/28/2021
Initial Date FDA Received05/14/2021
Supplement Dates Manufacturer Received04/28/2021
Supplement Dates FDA Received06/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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