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 Codes	Material Disintegration (1177); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Three days after intubation, it was found that the inflating tube has been removed from the tracheal tube itself. .
Additional Manufacturer Narrative
The inflation tube being removed from the tracheal tube would be an interruption in patient ventilation.This would cause the patient to be re-intubated thus causing a delay in ventilation and treatment.
Additional Manufacturer Narrative
The inflation tube being removed from the tracheal tube would be an interruption in patient ventilation.This would cause the patient to be re-intubated thus causing a delay in ventilation and treatment complaint was considered confirmed based on visual evidence provided by customer.A 24 month review was conducted and 4 additional complaints were identified related to this issue however no trend was observed.No lot number was provided for further investigation, however the vendor was notified of the incident.This incident was not identified as an increasing trend.No further action to be taken.
Event or Problem Description
Three days after intubation, it was found that the inflating tube has been removed from the tracheal tube itself. .

• 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: 19055615
• Report Number: 3000219639-2024-00034
• Device Sequence Number: 20842299
• Product Code: BTR
• UDI-Device Identifier: 00607411952753
• UDI-Public: 00607411952753
• 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): 04/05/2024

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?: 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: 03/08/2024
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 04/18/2024
• 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