MAUDE Adverse Event Report: BOUND TREE MEDICAL, LLC CURAPLEX; ADULT 7FT ETCO2 GAS SAMPLING LINE WITH ET-TUBE ADAPTER

Model Number	5107ET
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Output Problem (3005)
Health Effect - Clinical Code	Respiratory Failure (2484)
Date of Event	08/24/2024
Type of Reportable Event	Death
Event or Problem Description
Etco2 plugged into monitor, attached to a patient, monitor (lp15) noted to spontaneous xxx etco2 module on screen.Etco2 replaced and reattached to same monitor - same result.Additional monitor obtained, second etco2 probe attached and attached to ett - monitor successfully displayed etco2 without issue.Patient pronounced dead after further resuscitation efforts.Other: (b)(6).Two seperate devices were used in relation to this event, the first report number is 1314417-2025-00015.
Additional Manufacturer Narrative
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 25 mar 2025 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
Etco2 plugged into monitor, attached to a patient, monitor (lp15) noted to spontaneous xxx etco2 module on screen.Etco2 replaced and reattached to same monitor - same result.Additional monitor obtained, second etco2 probe attached and attached to ett - monitor successfully displayed etco2 without issue.Patient pronounced dead after further resuscitation efforts.Other: (b)(6).Two separate devices were used in relation to this event, the first report number is 1314417-2025-00015.
Additional Manufacturer Narrative
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 25 mar 2025 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.The complaint of "spontaneous xxx etco2 module on screen" regarding parts 301-5107et and 301-5707f-se was not confirmed.The root cause was not determined but could possibly be a result of user error.A risk assessment was performed and the ultimate risk was determined to be low which does not require escalation to the capa review board.There have been 9 other complaints regarding the same part and a similar issue within the 24 months preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.

• Brand Name: CURAPLEX
• Common Device Name: ADULT 7FT ETCO2 GAS SAMPLING LINE WITH ET-TUBE ADAPTER
• Manufacturer (Section D): BOUND TREE MEDICAL, LLC; 5000 tuttle crossing inc.; dublin OH 43016
• Manufacturer (Section G): SUNMED AP, LTD.; 6-9 zhufeng rd., qiannan indus; qianwu town, doumen district; zhuhai guangdong, china 51917 0; CH 519170
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 21693863
• Report Number: 1314417-2025-00016
• Device Sequence Number: 12974121
• Product Code: CCK
• UDI-Device Identifier: 00810071631863
• UDI-Public: (01)00810071631863
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K063813
• 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): 04/25/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 5107ET
• Device Catalogue Number: 301-5107ET
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/25/2025
• 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: Death
• Patient Sex: Unknown