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

Model Number	H-PFHV-70
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All information reasonably known as of 14 may 2025 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
When the patient was moving to bed after rehabilitation, the inflating tube was dislodged.The hospital said that the inflating tube was not positioned in the slit portion of the stream guard.
Additional Manufacturer Narrative
All information reasonably known as of 14 may 2025 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 that "when the patient was moving to bed after rehabilitation, the inflating tube was dislodged.Because the lot number is not available, we could not review the retained samples and dhr accordingly.The bonding process was verified and monitored; the bonding effect is judged by the sampling tension test in workshop per 4 hours.In this complaint, the tube was be intubated 4 days and it was found detached from the tubing after the patient moving, based on above information, well lead was unable to determine the root cause for this complaint.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 seventh complaint reported for part number i-pfhv-70, "leaking" failure mode.There were nine other complaints reported for part number i-pfhv-70 during the same timeframe.We will continue to monitor trends during our periodic complaint review meetings.Risk assessment: the ultimate risk is low, as that is the highest risk of the following 2 considerations: 1.Patient / caregiver.Performed risk assessment with rma-20024b rev 3 parker flex-tip endotracheal tubes which is sufficient for part number i-pfhv-70.The complaint aligns with risk id r25 with a potential cause of hazard being "1.Check valve leak.2.Cuff having pin hole 3.Damaged tubing 4.Leaky bonds" severity = 6-major, 2-improbable the risk is acceptable.Per table 1a in (b)(4), these levels indicate low risk.2.Regulatory / compliance: reviewed table 2 in (b)(4), and there is low regulatory / compliance risk.
Event or Problem Description
When the patient was moving to bed after rehabilitation, the inflating tube was dislodged.The hospital said that the inflating tube was not positioned in the slit portion of the stream guard.

• Brand Name: PARKER
• Common Device Name: ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 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 51143 4; JA 511434
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 22023868
• Report Number: 3000219639-2025-00047
• Device Sequence Number: 15258965
• Product Code: BTR
• UDI-Device Identifier: 00607411952739
• UDI-Public: (01)00607411952739
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: H-PFHV-70
• Device Catalogue Number: H-PFHV-70
• Device Lot Number: UNKNOW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 07/11/2025
• 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