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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALTER LABS SALTER LABS PARKER ENDOTRACHEAL TUBES
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SALTER LABS SALTER LABS PARKER ENDOTRACHEAL TUBES Back to Search Results
Model Number H-PSTDL-35-1
Medical Device Problem Code Difficult to Insert (1316)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/29/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Facility has only recently begun using this product.Event most likely due to transition to new product/unfamiliar with product characteristics.No serious injury was reported.
 
Event or Problem Description
Reporter states that the patient experienced airway trauma that led to a returned emergency visit.No additional treatment or hospitalization was required.There was no other serious injury reported.Reporter was not involved in the event, and has no further information.Reporter did not report a device defect, only that it was difficult to insert.
 
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Brand Name
SALTER LABS PARKER ENDOTRACHEAL TUBES
Common Device Name
TRACHEAL TUBE
Manufacturer (Section D)
SALTER LABS
2365 camino vida roble
carlsbad CA 92011
MDR Report Key7900157
Report Number3000219639-2018-00007
Device Sequence Number1433873
Product Code BTR
UDI-Device Identifier00607411959486
UDI-Public00607411959486
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K092886
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/21/2018
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
Operator of Device Health Professional
Device Model NumberH-PSTDL-35-1
Device Catalogue NumberH-PSTDL-35-1
Device Lot Number15030CO411L
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/29/2018
Initial Report FDA Received Date09/21/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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