MAUDE Adverse Event Report: SALTER LABS PARKER; ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 7.5MM

Model Number	H-PFHV-75
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Interruption in therapy caused the patient to be re-intubated.The inability for the connector to be held and required to be connected to the circuit of ventilator would cause an interruption in therapy.The incident would require intervention; a deflated cuff could cause loss of delivered volume.
Event or Problem Description
Endotracheal tube is unable to hold connector which require to connect to circuit of ventilator to provide ventilation. .
Event or Problem Description
Endotracheal tube is unable to hold connector which require to connect to circuit of ventilator to provide ventilation. .
Additional Manufacturer Narrative
Interruption in therapy caused the patient to be re-intubated.The inability for the connector to be held and required to be connected to the circuit of ventilator would cause an interruption in therapy.The incident would require intervention; a deflated cuff could cause loss of delivered volume the complaint of "endotracheal tube is unable to hold connector which require to connect to circuit of ventilator to provide ventilation" regarding part h-pfhv-75 was not confirmed due to lack of photo or sample.The root cause cannot be determined but could possibly be a result of an incompatible connector.A risk assessment was performed using rma-20024b, rev 1 and the severity rating was determined to be 8/10 which does require the initiation of a capa.There have been 0 complaints against h-pfhv-75 in the past 24 months.An inventory analysis was completed and no non-conformances were found.A resolution letter was sent to the customer.

• Brand Name: PARKER
• Common Device Name: ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 7.5MM
• 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: 17794271
• Report Number: 3000219639-2023-00026
• Device Sequence Number: 7490848
• Product Code: BTR
• UDI-Device Identifier: 00607411952746
• UDI-Public: 00607411952746
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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: H-PFHV-75
• Device Catalogue Number: H-PFHV-75
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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