MAUDE Adverse Event Report: AIRLIFE AIRLIFE; AIRLIFE ISOTHERMAL BREATHING CIRCUIT ACCESSORY SPECIAL PRODUCT REQUEST

Model Number	5979-504
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available but has not yet been received by the manufacturer.A review of the device history record is in-progress all information reasonably known as of 11 nov 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 sun med holdings llc.Represents all the information known 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 sun med holdings llc.Sun med holdings llc has no independent knowledge of the event reported, but is relaying information provided by the user facility where the incident occurred.This product incident is documented in the sun med holdings complaint database and identified as (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 sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
It was reported that the product is supposed to be hollow or open to allow flow to pass through.However, it was not fully open and obstructed the flow.There was no reported delay in therapy, nor any harm or injury resulting from this event.
Additional Manufacturer Narrative
The complaint product was not returned for evaluation; however, the reporter provided photographic evidence.Analysis of the photo confirmed the reported complaint.The root cause was determined to be equipment-related, as a result, the etal process will be modified to include an occlusion test during the molding process.The device history record for lot 0004322301 was reviewed, and confirmed that the product was manufactured according to specifications.The documented udi is based on the stock/product/lot number code provided by the reporter.Per the device history record (dhr), this product does not have an expiration date.All information reasonably known as of 05 dec 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 sun med holdings llc.Represents all the information known 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 sun med holdings llc.Sun med holdings llc has no independent knowledge of the event reported, but is relaying information provided by the user facility where the incident occurred.This product incident is documented in the sun med holdings complaint database and identified as (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 sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
It was reported that the product is supposed to be hollow or open to allow flow to pass through.However, it was not fully open and obstructed the flow.There was no reported delay in therapy, nor any harm or injury resulting from this event.

• Brand Name: AIRLIFE
• Common Device Name: AIRLIFE ISOTHERMAL BREATHING CIRCUIT ACCESSORY SPECIAL PRODUCT REQUEST
• Manufacturer (Section D): AIRLIFE; 2710 northridge dr. nw, suite; grand rapids MI 49544
• Manufacturer (Section G): SUNMED PRODUCTOS UROLOGOS DE MEXICO S; no. 85 parque indus. mexicali; mexicali, baja california 84160 ; MX 84160
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw, suite a; grand rapids, MI 49544
• MDR Report Key: 23526616
• Report Number: 1314417-2025-00093
• Device Sequence Number: 15738494
• Product Code: BZE
• UDI-Device Identifier: 10889483587324
• UDI-Public: (01)10889483587324(11)250501(10)0004322301
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K993833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 5979-504
• Device Catalogue Number: 5979-504
• Device Lot Number: 0004322301
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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
• Patient Sex: Unknown