MAUDE Adverse Event Report: SALTER LABS SALTER LABS; ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 8.0MM

Model Number	I-PFHV-80
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Air was leaking from the cuff. .
Additional Manufacturer Narrative
Interruption in therapy caused the patient to be re-intubated.The cuff leak would delate the cuff causing the patient to require re-intubation.
Event or Problem Description
Air was leaking from the cuff. .
Additional Manufacturer Narrative
Interruption in therapy caused the patient to be re-intubated.The cuff leak would delate the cuff causing the patient to require re-intubation.The complaint investigation was performed based on the content of the issue reported.Based on the photo images provided by the customer the leaks were confirmed based on the defective photo images provided.A possible root cause of the hazard is leaky bonds.No lot number was provided; however, dhr review was not performed because the product is a purchased finished good.A risk assessment was performed, and the ultimate risk was determined to be low which does not require reporting to the capa review board.There have been seven (7) complaints regarding this part number within the 24-month timeframe.We will continue to monitor trends during our periodic complaint review meetings.

• Brand Name: SALTER LABS
• Common Device Name: ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 8.0MM
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18823007
• Report Number: 3000219639-2024-00017
• Device Sequence Number: 4525865
• Product Code: BTR
• UDI-Device Identifier: 10607411952750
• UDI-Public: 10607411952750
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

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 Number: I-PFHV-80
• Device Catalogue Number: I-PFHV-80
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown