MAUDE Adverse Event Report: AIRLIFE VITAL SIGNS; VITAL SIGN LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT,

Model Number	AFPXXXXX
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: (appropriate term/code not available): rubber band.The actual complaint product was not returned for evaluation; additionally, no photographic/videographic evidence was provided by the reporter.However, based on the event as reported, the complaint is considered to be not confirmed as the product is manufactured according to a validated design, and its configuration does not include glue or welding; therefore, the reported issue is not a defect that would be associated with the reported device.The device history record for lot 0004300582 was reviewed and the product was produced according to product specifications.All information reasonably known as of 23 jun 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
Associated with separate units, involving three different patients.This is the first of three reports.Refer to 1314417-2026-00042 for the first report.Refer to 1314417-2026-00043 for the second report.Refer to 1314417-2026-00044 for the third report.It was reported, that the connection came apart on the adult anesthesia circuit due to the rubber band somehow started to roll up due to external pressure.It was additionally reported, the medical staff acted quickly, the tube was replaced, and no harm came to the patient.

• Brand Name: VITAL SIGNS
• Common Device Name: VITAL SIGN LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT,
• Manufacturer (Section D): AIRLIFE; 2710 north ridge dr nw; ste a; grand rapids MI
• Manufacturer (Section G): SUNMED MEDICAL; productos urologos de mexico s; no. 85 parque indus. mexicali; mexicali baja california, mx ; MX
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 25602608
• Report Number: 1314417-2026-00042
• Device Sequence Number: 20217188
• Product Code: CAI
• UDI-Device Identifier: 10190752122338
• UDI-Public: (01)10190752122338(10)0004300582(11)241024
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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: AFPXXXXX
• Device Catalogue Number: AFPXXXXX
• Device Lot Number: 0004300582
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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