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

Model Number	H-PFHV-75
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	Decreased Respiratory Rate (2485); Unintended Extubation (4564)
Date of Event	09/17/2024
Type of Reportable Event	Death
Event or Problem Description
It was stated by customer that "while intubating the patient, the inflating tube was dislodged and the cuff atrophied.The patient later died.The hospital was of the opinion that there was no causal relationship between the dislodged inflating tube and the death.We do not know the cause-and-effect relationship".
Additional Manufacturer Narrative
H6: 4756 (appropriate impact term/code not available): endotracheal tube the product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 05 dec 2024 has been included in the 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 is 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 a airlife product is defective or causes serious injury.
Event or Problem Description
It was stated by customer that "while intubating the patient, the inflating tube was dislodged and the cuff atrophied.The patient later died.The hospital was of the opinion that there was no causal relationship between the dislodged inflating tube and the death.We do not know the cause-and-effect relationship".
Additional Manufacturer Narrative
H6: 4756 (appropriate impact term/code not available): endotracheal tube.The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 05 dec 2024 has been included in the 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 is 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 a airlife product is defective or causes serious injury.Complaint was considered confirmed based on customer narrative of events.A 24 month review was conducted and 1 additional complaints were identified related to this issue however no trend was observed.The lot number was not provided, however the vendor was notified of the incident.This incident was not identified as an increasing trend.No further action to be taken.

• Brand Name: PARKER
• Common Device Name: ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 7.5MM
• 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: 20858113
• Report Number: 3000219639-2024-00130
• Device Sequence Number: 19848226
• Product Code: BTR
• UDI-Device Identifier: 00607411952746
• UDI-Public: (01)00607411952746
• 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: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: H-PFHV-75
• Device Catalogue Number: H-PFHV-75
• 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: 11/05/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 12/30/2024
• 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: Death
• Patient Sex: Unknown