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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALTER LABS SALTER LABS; BX20 - MAC 2 ,3, 4 DISPOSABLE LED BLADE, MILLER 2, D BLADE MEDIUM D HANDLE
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SALTER LABS SALTER LABS; BX20 - MAC 2 ,3, 4 DISPOSABLE LED BLADE, MILLER 2, D BLADE MEDIUM D HANDLE Back to Search Results
Model Number 1022.C, 1023.C,1024.C,1032.C,2015.C
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 12/15/2021
Event Type  malfunction  
Event Description
Reported provider events that included no lighting out of the package, intermittent flickering, flickering upon insertion into the oral cavity when lifting anatomy and pressure applied.
 
Manufacturer Narrative
The defect caused the patient to have a delay in the intubation procedure.There was no patient injury, this incident will be reported.Intubation was hindered which delays in establishing a protected airway.Which increases the risk to the patient.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.
 
Manufacturer Narrative
The defect caused the patient to have a delay in the intubation procedure.There was no patient injury, this incident will be reported.Intubation was hindered which delays in establishing a protected airway.Which increases the risk to the patient.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.
 
Event Description
Reported provider events that included no lighting out of the package, intermittent flickering, flickering upon insertion into the oral cavity when lifting anatomy and pressure applied.
 
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Brand Name
SALTER LABS
Type of Device
BX20 - MAC 2 ,3, 4 DISPOSABLE LED BLADE, MILLER 2, D BLADE MEDIUM D HANDLE
Manufacturer (Section D)
SALTER LABS
30 spur dr
el paso CA 79906
Manufacturer (Section G)
SALTER LABS
2710 northridge dr nw suite a
grand rapids MI 49544
Manufacturer Contact
melissa brickley
2710 northridge dr
grand rapids, MI 49544
6162598415
MDR Report Key13261867
MDR Text Key286058229
Report Number3000219639-2022-00003
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/14/2022
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? Yes
Device Operator Health Professional
Device Model Number1022.C, 1023.C,1024.C,1032.C,2015.C
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/15/2021
Initial Date FDA Received01/14/2022
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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