MAUDE Adverse Event Report: AIRLIFE AIRLIFE; AIRLIFE ADULT OXYGEN MASK VINYL, UNDER-THE-CHIN, MEDIUM CONCENTRATION MASK

Model Number	001361
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the report is not available for evaluation; however, analysis of photographic evidence provided by the reporter is in progress.A review of the device history record is in-progress.All information reasonably known as of (b)(6) 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(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 healthcare facility reported, difficulty connecting/disconnecting tubing to connectors in the operating room/acute surgical unit (or/asu), which resulted in the patient de-saturating due to improper connection(s).No information was provided concerning if any medical intervention was required; the patient condition was reported to be stable.
Event or Problem Description
The healthcare facility reported, difficulty connecting/disconnecting tubing to connectors in the operating room/acute surgical unit (or/asu), which resulted in the patient de-saturating due to improper connection(s).No information was provided concerning if any medical intervention was required; the patient condition was reported to be stable.
Additional Manufacturer Narrative
Additional information-investigation completion: d4; h2; h6 the actual complaint product was not returned for evaluation; 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.Without a sample to perform functional evaluation, a root cause could not be determined.The device history record for lot 0004331350 was reviewed and the product was produced according to product specifications.All information reasonably known as of 05 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 complaint-13131 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.

• Brand Name: AIRLIFE
• Common Device Name: AIRLIFE ADULT OXYGEN MASK VINYL, UNDER-THE-CHIN, MEDIUM CONCENTRATION MASK
• Manufacturer (Section D): AIRLIFE; 2710 north ridge dr nw; ste a; grand rapids MI
• Manufacturer (Section G): SUN MED; 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: 23490763
• Report Number: 1314417-2025-00092
• Device Sequence Number: 8533580
• Product Code: CAT
• UDI-Device Identifier: 10889483570128
• UDI-Public: (01)10889483570128(10)0004331350(17)300821(11)250822
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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: 001361
• Device Catalogue Number: 001361
• Device Lot Number: 0004331350
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown