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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALTER LABS SALTER LABS PARKER MEDICAL ENDOTRACHEAL TUBE
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SALTER LABS SALTER LABS PARKER MEDICAL ENDOTRACHEAL TUBE Back to Search Results
Model Number H-PFST-70-10
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code Death (1802)
Date of Event 06/08/2018
Type of Reportable Event Death
Additional Manufacturer Narrative
Based on this information, there was a device malfunction.Photos provided show cuff failure.Death occurred but relationship to device malfunction not established.Cause most likely due to multiple disease states.This is a companion report to facility report (b)(4).
 
Event or Problem Description
Patient underwent surgery and subsequently developed decreased oxygen saturation.X-ray revealed pneumomediastinum.Patient was intubated and placed on ventilator.Patient was determined to have a subacute right aca infarct and chronic right mca infarct.Patient expired on (b)(6) 2018.
 
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Brand Name
SALTER LABS PARKER MEDICAL ENDOTRACHEAL TUBE
Common Device Name
ENDOTRACHEAL TUBE
Manufacturer (Section D)
SALTER LABS
2365 camino vida roble
carlsbad CA 92011
MDR Report Key7674163
Report Number3000219639-2018-00005
Device Sequence Number848364
Product Code BTR
UDI-Device Identifier00607411958014
UDI-Public00607411958014
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K042683
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 07/10/2018
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
Operator of Device Health Professional
Device Model NumberH-PFST-70-10
Device Catalogue NumberH-PFST-70-10
Device Lot Number1708ST14001K
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/14/2018
Initial Report FDA Received Date07/10/2018
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 Death;
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