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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALTER LABS SALTER LABS PARKER MEDICAL ENDOTRACHEAL TUBES
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SALTER LABS SALTER LABS PARKER MEDICAL ENDOTRACHEAL TUBES Back to Search Results
Model Number H-PFST-75
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code Hypoxia (1918)
Date of Event 06/06/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Based on this information, there was a device malfunction.Photos provided show cuff failure.Patient experienced respiratory insufficiency with no other injury reported.Reference user facility report 250965414-2018-001.
 
Event or Problem Description
Patient underwent surgery and subsequently developed respiratory insufficiency.Ct scan revealed pneumomediastinum.Patient was transferred for further evaluation.No other injury identified.
 
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Brand Name
SALTER LABS PARKER MEDICAL ENDOTRACHEAL TUBES
Common Device Name
ENDOTRACHEAL TUBES
Manufacturer (Section D)
SALTER LABS
2365 camino vida roble
carlsbad CA 92011
MDR Report Key7674235
Report Number3000219639-2018-00006
Device Sequence Number1577877
Product Code BTR
UDI-Device Identifier00607411959288
UDI-Public00607411959288
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? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberH-PFST-75
Device Catalogue NumberH-PFST-75
Device Lot Number1708ST1400L
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
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