MAUDE Adverse Event Report: AIRLIFE AIRLIFE STERILE WATER FOR INHALATION; STERILE WATER FOR INHALATION, USP, 500 ML

Model Number	002620
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility med sun report 3902560000-2025-8151 reported: patient was having difficulty breathing with retractions.When equipment was checked, the airlife bubble humidification system was leaking oxygen from the front.After verification from a second employee, the device was exchanged with a new airlife system.The rt [respiratory therapist] and rn [registered nurse] called the medical team to the bedside and while they were there, rt noticed the crack in the humification system.The patient was essentially not getting any oxygen.He replaced the bottle, and the baby recovered over time.He couldn't say whether it was cracked when they opened it or the nurse somehow cracked it during set up.It was additionally reported: the patient had been extubated [prior to the event] after an hour the nurse called because the patient was retracting and had an increased work of breathing (wob); the bottle itself was found to be cracked.
Additional Manufacturer Narrative
(appropriate term/code not available): humidification system the actual complaint product was not returned for evaluation; however, the reporter provided photographic/videographic evidence; analysis of the photographic evidence confirmed the complaint as reported.A review of the device history record is in-progress.All information reasonably known as of 19 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 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 sun med holdings llc.Sun med holdings llc.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 sun med holdings complaint database and identified as complaint-13176 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 sun med holdings llc.Product is defective or caused serious injury.
Additional Manufacturer Narrative
Additional information-investigation completion: d4; h2; h6.(appropriate term/code not available): humidification system.The actual complaint product was not returned for evaluation; however, the reporter provided photographic/videographic evidence; analysis of the photographic evidence confirmed the complaint as reported.The root cause was not determined.The device history record for lot tl2410065 was reviewed and the product was produced according to product specifications.All information reasonably known as of 22 jan 2026 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 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 sun med holdings llc.Sun med holdings llc.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 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 an sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
The user facility med sun report (b)(4) reported: patient was having difficulty breathing with retractions.When equipment was checked, the airlife bubble humidification system was leaking oxygen from the front.After verification from a second employee, the device was exchanged with a new airlife system.The rt [respiratory therapist] and rn [registered nurse] called the medical team to the bedside and while they were there, rt noticed the crack in the humification system.The patient was essentially not getting any oxygen.He replaced the bottle, and the baby recovered over time.He couldn't say whether it was cracked when they opened it or the nurse somehow cracked it during set up.It was additionally reported: the patient had been extubated [prior to the event] after an hour the nurse called because the patient was retracting and had an increased work of breathing (wob); the bottle itself was found to be cracked.
Additional Manufacturer Narrative
(appropriate term/code not available): humidification system.The actual complaint product was not returned for evaluation; however, the reporter provided photographic/videographic evidence; analysis of the photographic evidence confirmed the complaint as reported.A review of the device history record is in-progress.All information reasonably known as of 19 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 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 sun med holdings llc.Sun med holdings llc.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 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 an sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
The user facility med sun report (b)(4) reported: patient was having difficulty breathing with retractions.When equipment was checked, the airlife bubble humidification system was leaking oxygen from the front.After verification from a second employee, the device was exchanged with a new airlife system.The rt [respiratory therapist] and rn [registered nurse] called the medical team to the bedside and while they were there, rt noticed the crack in the humification system.The patient was essentially not getting any oxygen.He replaced the bottle, and the baby recovered over time.He couldn't say whether it was cracked when they opened it or the nurse somehow cracked it during set up.It was additionally reported: the patient had been extubated [prior to the event] after an hour the nurse called because the patient was retracting and had an increased work of breathing (wob); the bottle itself was found to be cracked.

• Brand Name: AIRLIFE STERILE WATER FOR INHALATION
• Common Device Name: STERILE WATER FOR INHALATION, USP, 500 ML
• Manufacturer (Section D): AIRLIFE; 2710 north ridge dr nw; ste a; grand rapids MI
• Manufacturer (Section G): AIR LIFE; productos urologos de mexico s; no. 85 parque indus. mexicali; mexicali baja california, mx, mex 84160 ; MX 84160
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 23600764
• Report Number: 1314417-2025-00097
• Device Sequence Number: 9258692
• Product Code: BTT
• UDI-Device Identifier: 10889483571477
• UDI-Public: (01)10889483571477(10)TL2410065(17)261031(11)241031
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2026

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: 002620
• Device Catalogue Number: 002620
• Device Lot Number: TL2410065
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 10/20/2025; 12/04/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 11/19/2025; 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 4 DA
• Patient Sex: Female