MAUDE Adverse Event Report: PARKER MEDICAL PARKER; ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 8.0MM, 7.0MM

Model Number	I-PFHV-70-10,I-PFHV-80-10
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All information reasonably known as of 02 july 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury.
Event or Problem Description
Frequently receive alarms for elevated cuff pressure or leakage.Our problem is leakage past the cuff at relatively high ventilator pressures.Experience leakage past the cuff with parker tubes due to the elongated cuff when the tube is somewhat small relative to the tracheal size.
Additional Manufacturer Narrative
All information reasonably known as of 02 july 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury.The complaint reported "frequently receive alarms for elevated cuff pressure or leakage.Our problem is leakage past the cuff at relatively high ventilator pressures.Experience leakage past the cuff with parker tubes due to the elongated cuff when the tube is somewhat small relative to the tracheal size." the complaint investigation was performed based on the content of the issue reported.Based on the complaint report no patient was affected.There were no photo images or videos of the reported issue; therefore, the complaint was unable to be confirmed and no root cause was identified.A risk assessment was performed, and the ultimate risk was determined to be low which does not require reporting to the capa review board.This is the third (3) complaint reported for part number i-pfhv-70-10 for leaking during this timeframe.This is the second (2) complaint reported for part number i-pfhv-80-10 for leaking during this timeframe.We will continue to monitor trends during our periodic complaint review meetings.
Event or Problem Description
Frequently receive alarms for elevated cuff pressure or leakage.Our problem is leakage past the cuff at relatively high ventilator pressures.Experience leakage past the cuff with parker tubes due to the elongated cuff when the tube is somewhat small relative to the tracheal size.

• Brand Name: PARKER
• Common Device Name: ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 8.0MM, 7.0MM
• Manufacturer (Section D): PARKER MEDICAL; 9457 s university blvd; pmb 331; highlands ranch CO 80126
• Manufacturer (Section G): WELL LEAD MEDICAL CO; c-4 jinhu industrial estate; hualong; panyu, guangzhou TX 51143 4; JA 511434
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 19660370
• Report Number: 3000219639-2024-00054
• Device Sequence Number: 6847914
• Product Code: BTR
• UDI-Device Identifier: 00607411952753
• UDI-Public: (01)00607411952739,(01)00607411952753
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K984528
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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-70-10,I-PFHV-80-10
• Device Catalogue Number: I-PFHV-70-10,I-PFHV-80-10
• 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: 06/04/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/17/2024
• 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