MAUDE Adverse Event Report: Airlife Vital Signs; Vital Signs Adult Anesthesia Breathing Circuit

Model Number	A4F52014
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Malfunction

• Brand Name: Vital Signs
• Common Device Name: Vital Signs Adult Anesthesia Breathing Circuit
• Manufacturer (Section D): Airlife; 2710 north ridge dr nw; ste a; grand rapids MI
• Manufacturer (Section G): SUN MED-MEXICALI; 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: 50150104
• Report Number: 1314417-2026-00050
• Device Sequence Number: 9261461
• Product Code: CAI
• UDI-Device Identifier: 10889483592076
• UDI-Public: (01)10889483592076(10)0004350994
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: A4F52014
• Device Catalogue Number: A4F52014
• Device Lot Number: 0004350994
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2026
• 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